Maine Standards Co

FDA Filings

This page includes the latest FDA filings for Maine Standards Co. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 1226774
• FEI Number: 3003407015
• Name: MAINE STANDARDS CO.
• Owner & Operator: MAINE STANDARDS CO.
• Contact Address: 221 US Route 1 --; Cumberland Foreside ME 04110 US
• Official Correspondent:
  • Heather Buckley
  • x-207-8921300-x
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 221 US Route 1 ; Cumb Foreside, ME 04110 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GIL MAINE STANDARDS CO.	Validate Fibrinogen st Calibration Verification/Linearity Test Kit, product code 904st	2018-01-16
GIL MAINE STANDARDS CO.	Validate Fibrinogen se Calibration Verification/Linearity Test Kit, product code 904se	2018-01-16
GIL MAINE STANDARDS CO.	Validate Fibrinogen il Calibration Verification/Linearity Test Kit, product code 904il	2018-01-16
JJX MAINE STANDARDS CO.	VALIDATE hsTNT Calibration Verification/Linearity Test Kit, product code 405ro	2018-01-02
JJX MAINE STANDARDS CO.	VALIDATE Whole Blood Glucose Calibration Verification/Linearity Test Kit, product code 607ro	2018-01-02
JJX MAINE STANDARDS CO.	VALIDATE Procalcitonin Calibration Verification/Linearity Test Kit, product codes: 403ab, 403ro	2018-01-02
JJX MAINE STANDARDS CO.	VALIDATE HbA1c Calibration Verification/Linearity Test Kit, product codes: 605, 605to	2018-01-02
JJX MAINE STANDARDS CO.	VALIDATE Ferritin Calibration Verification/Linearity Test Kit, product code 307	2018-01-02
JJY MAINE STANDARDS CO.	VALIDATE UC4 Calibration Verification/Linearity Test Kit, product code: 704sa	2017-11-15
JJY MAINE STANDARDS CO.	VALIDATE UC1 Calibration Verification/Linearity Test Kit, product code: 701sa	2017-11-15
JJY MAINE STANDARDS CO.	VALIDATE Tumor Markers Calibration Verification/Linearity Test Kit, product codes: 407re, 407sa	2017-11-15
JJY MAINE STANDARDS CO.	VALIDATE SP3 Calibration verification/linearity test kit, product code: 603ro	2017-11-15
JJY MAINE STANDARDS CO.	VALIDATE SP2 Calibration verification/linearity test kit, product codes: 602bc, 602re	2017-11-15
JJY MAINE STANDARDS CO.	VALIDATE SP1 Calibration Verification/Linearity Test Kit, product code: 601ro	2017-11-15
JJY MAINE STANDARDS CO.	VALIDATE LP2 Calibration Verification/Linearity Test Kit, product code: 507ro	2017-11-15
JJY MAINE STANDARDS CO.	VALIDATE IBC Calibration Verification/Linearity Test Kit, product codes: 203ro, 203sd, 203vt	2017-11-15
JJY MAINE STANDARDS CO.	VALIDATE High Sensitive Troponin Calibration Verification/Linearity Test Kit, product code 405ro	2017-11-15
JJY MAINE STANDARDS CO.	VALIDATE Fertility 2 Calibration Verification/Linearity Test Kit, product code: 504re	2017-11-15
JJY MAINE STANDARDS CO.	VALIDATE Fertility 1 Calibration Verification/Linearity Test Kit, product code: 502re	2017-11-15
JJY MAINE STANDARDS CO.	VALIDATE CM3 Calibration verification/linearity test kit, product code: 409ro	2017-11-15
JJY MAINE STANDARDS CO.	VALIDATE Body Fluids Calibration Verification/Linearity Test Kit, product codes: 205bf, 205ro	2017-11-15
JJY MAINE STANDARDS CO.	VALIDATE Body Fluids 2 Calibration Verification/Linearity Test Kit, product code: 206ro	2017-11-15
JJY MAINE STANDARDS CO.	VALIDATE Anemia Calibration verification/linearity test kit, product codes: 308bc, 308re	2017-11-15
GGN MAINE STANDARDS CO.	Validate Heparin st calibration verification /linearity kit	2017-10-23
GGN MAINE STANDARDS CO.	Validate Heparin se calibration verification /linearity kit, product code 903se	2017-10-23
PMN K170864 | GGN MAINE STANDARDS CO.	VALIDATE D-Dimer Calibration Verification/Linearity Test Kit	2017-06-22
PMN K163498 | GGN MAINE STANDARDS CO.	Validate Heparin Calibration Verification/Linearity Test Kit	2017-03-17
PMN K162705 | GGN MAINE STANDARDS CO.	VALIDATE D-Dimer Calibration Verification/Linearity Test Kit	2017-01-10
PMN K152961 | GGN MAINE STANDARDS CO.	VALIDATE D-Dimer Calibration Verification/Linearity Test Kit	2016-06-06
PMN K142964 | JJY MAINE STANDARDS CO.	VALIDATE Anemia Calibration Verification/Linearity Test Kit, Product code 305	2015-07-16
OHQ MAINE STANDARDS CO.	Validate whole blood glucose unassayed calibration verification/linearity test kit, product code 607	2015-05-01
OHQ MAINE STANDARDS CO.	Validate Tumor Markers unassayed calibration verification/linearity test kit, Product code 407sa	2015-05-01
OHQ MAINE STANDARDS CO.	Validate Tumor Markers unassayed calibration verification/linearity test kit, Product code 407re	2015-05-01
OHQ MAINE STANDARDS CO.	Validate Tumor Markers unassayed calibration verification/linearity test kit, Product code 407	2015-05-01
OHQ MAINE STANDARDS CO.	Validate SP2 unassayed calibration verification/linearity test solution, Product code 602	2015-05-01
OHQ MAINE STANDARDS CO.	Validate SP2 unassayed calibration verification/linearity test kit, Product code 602re	2015-05-01
OHQ MAINE STANDARDS CO.	Validate SP2 unassayed calibration verification/linearity test kit, Product code 602bc	2015-05-01
OHQ MAINE STANDARDS CO.	Validate IBCsd Unassayed calibration verification/linearity test kit, Product code 203sd	2015-05-01
OHQ MAINE STANDARDS CO.	Validate IBCro Unassayed calibration verification/linearity test solution, Product code 203ro	2015-05-01
OHQ MAINE STANDARDS CO.	Validate HbA1c unassayed calibration verification/linearity test kit, Product Code 605	2015-05-01
OHQ MAINE STANDARDS CO.	Validate Fertility 2 unassayed calibration verification/linearity test kit Product Code 504re	2015-05-01
OHQ MAINE STANDARDS CO.	Validate Fertility 1 unassayed calibration verification/linearity test kit Product Code 502re	2015-05-01
OHQ MAINE STANDARDS CO.	Validate Ferritin unassayed calibration verification/linearity test solution, Product code 307	2015-05-01
OHQ MAINE STANDARDS CO.	VALIDATE Anemia unassayed calibration verification/linearity test kit, Product codes 308bc, 308re	2015-05-01
PMN K133550 | JJX MAINE STANDARDS CO.	Validate Ferritin product code 306	2014-05-05
PMN K133550 | JJX MAINE STANDARDS CO.	Validate Ferritin Unassayed Calibration Verification Test Solution, Product Code 307	2014-05-05
PMN K133550 | JJX MAINE STANDARDS CO.	VALIDATE Ferritin Calibration Verification/Linearity Test Kit	2014-05-05
PMN K123127 | JJX MAINE STANDARDS CO.	Validate PSA product code 406re	2013-07-26
PMN K123127 | JJX MAINE STANDARDS CO.	Validate PSA product code 406bc	2013-07-26
PMN K123127 | JJX MAINE STANDARDS CO.	VALIDATE PSA Calibration Verification/Linearity Test Kit	2013-07-26
PMN K123127 MAINE STANDARDS CO.	VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406	2013-06-14
JQP MAINE STANDARDS CO.	MSDRx Data Reduction Software	2013-04-17
PMN K113524 | JJX MAINE STANDARDS CO.	Validate Vitamin D product code 506vt	2012-03-01
PMN K113524 | JJX MAINE STANDARDS CO.	Validate Vitamin D Calibration Verification/ Linearity Test Kit, product code 506ab	2012-03-01
PMN K113524 | JJX MAINE STANDARDS CO.	Validate VIT D product code 506	2012-03-01
PMN K113524 | JJX MAINE STANDARDS CO.	VALIDATE VIT D Calibration Verification / Linearity Test Kit	2012-03-01
PMN K113524 MAINE STANDARDS CO.	VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT	2012-01-27
PMN K110880 | JJY MAINE STANDARDS CO.	VALIDATE? GC3 Calibration Verification / Linearity Test Kit	2011-10-26
PMN K103271 | JJY MAINE STANDARDS CO.	MSC Lipid Control	2011-10-26
PMN K103271 MAINE STANDARDS CO.	MSC LIPID CONTROL	2011-01-25
PMN K091225 | JJY MAINE STANDARDS CO.	Validate GC4 product codes: 1400ab, 1400au, 1400bc, 1400re, 1400ri, 1400sa, 1400sd, 1400vt	2009-10-05
PMN K091225 | JJY MAINE STANDARDS CO.	Validate GC3 product codes: 1300ab, 1300au, 1300bcc, 1300re, 1300sa, 1300sd, 1300vt	2009-10-05
PMN K091225 | JJY MAINE STANDARDS CO.	Validate GC2 product codes: 1200ab, 1200au, 1200bc, 1200re, 1200sa, 1200sd, 1200vt	2009-10-05
PMN K091225 | JJY MAINE STANDARDS CO.	Validate GC1, GC2, GC3 and GC4 Cali	2009-10-05
PMN K091225 | JJY MAINE STANDARDS CO.	Validate GC1 product codes:1100ab, 1100au, 1100bc, 1100ri, 1100ro, 1100sa, 1100sd, 1100sv, 1100vt	2009-10-05
PMN K090475 | JJY MAINE STANDARDS CO.	Validate hsCRP Calibration Verification Linearity Test Kit product code 404ro	2009-10-05
PMN K090475 | JJY MAINE STANDARDS CO.	Validate CM2vt Calibration Verification Linearity Test Kit, product code 402vt	2009-10-05
PMN K090475 | JJY MAINE STANDARDS CO.	Validate CM2 product code 402re	2009-10-05
PMN K090475 | JJY MAINE STANDARDS CO.	Validate CM2 product code 402bc	2009-10-05
PMN K090475 | JJY MAINE STANDARDS CO.	Validate CM2 product code 402ab	2009-10-05
PMN K090475 | JJY MAINE STANDARDS CO.	VALIDATE CM2 Calibration Verification/Linearity Test Set	2009-10-05
PMN K090475 | JJY MAINE STANDARDS CO.	CM2 Calibration Verification/Linear	2009-10-05
PMN K083891 | JJY MAINE STANDARDS CO.	Validate THY product code 901re	2009-10-05
PMN K083891 | JJY MAINE STANDARDS CO.	Validate THY product code 901bc	2009-10-05
PMN K083891 | JJY MAINE STANDARDS CO.	VALIDATE Thyroid Calibration Verification Test Set	2009-10-05
PMN K083891 | JJY MAINE STANDARDS CO.	THY Calibration Verification Test S	2009-10-05
PMN K091225 MAINE STANDARDS CO.	VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET	2009-06-25
PMN K090475 MAINE STANDARDS CO.	VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402	2009-04-16
PMN K083891 MAINE STANDARDS CO.	VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901	2009-03-23
PMN K082067 | JJY MAINE STANDARDS CO.	MSC Lipid Control (assayed)	2008-10-03
PMN K082067 MAINE STANDARDS CO.	MSC LIPID CONTROL	2008-08-22
PMN K020450 | JJY MAINE STANDARDS CO.	Validate Chem 8 product code 108	2007-11-12
PMN K020450 | JJY MAINE STANDARDS CO.	VALIDATE Chem 8 Calibration Verification Test Set	2007-11-12
PMN K020450 | JJY MAINE STANDARDS CO.	MSC Chem 8 Calibration Verification Test Set	2007-11-12
PMN K013265 | JJY MAINE STANDARDS CO.	VALIDATE Chem 7 Calibration Verification Test Set	2007-11-12
PMN K072246 | JJY MAINE STANDARDS CO.	VALIDATE SP1 Calibration Verification Test Set	2007-11-01
PMN K072246 | JJY MAINE STANDARDS CO.	SP1 Calibration Verification Test Set	2007-11-01
PMN K062501 | JJX MAINE STANDARDS CO.	VALIDATE Thyroid Calibration Verification Test Set	2007-11-01
PMN K062501 | JJX MAINE STANDARDS CO.	Thyroid Calibration Verification Test Set	2007-11-01
PMN K053247 | JJY MAINE STANDARDS CO.	Validate CM1 product code 401db	2007-11-01
PMN K053247 | JJY MAINE STANDARDS CO.	Validate CM1 product code 401bc	2007-11-01
PMN K053247 | JJY MAINE STANDARDS CO.	Validate CM1 product code 401ab	2007-11-01
PMN K053247 | JJY MAINE STANDARDS CO.	VALIDATE Cardiac Marker Calibration Verification Test Set	2007-11-01
PMN K050504 | JJY MAINE STANDARDS CO.	VALIDATE Urine Chemistry Calibration Verification Test Set	2007-11-01
PMN K050504 | JJY MAINE STANDARDS CO.	VALIDATE UC6 Urine Chemistry Verification Test Set	2007-11-01
PMN K050504 | JJY MAINE STANDARDS CO.	VALIDATE UC5 Urine Chemistry Verification Test Set	2007-11-01
PMN K050504 | JJY MAINE STANDARDS CO.	VALIDATE UC4 Urine Chemistry Verification Test Set	2007-11-01
PMN K050504 | JJY MAINE STANDARDS CO.	VALIDATE UC1 Urine Chemistry Verification Test Set	2007-11-01
PMN K050504 | JJY MAINE STANDARDS CO.	VALIDATE OSMO Urine Chemistry Verification Test Set	2007-11-01
PMN K050504 | JJY MAINE STANDARDS CO.	UC6 product code 706af	2007-11-01
PMN K050504 | JJY MAINE STANDARDS CO.	UC5 product codes 705au, 705bcc, 705db, 705ri, 705ro, 705vt	2007-11-01
PMN K050504 | JJY MAINE STANDARDS CO.	UC4 product codes 704au, 704bc, 704db, 704ri, 704ro	2007-11-01
PMN K050504 | JJY MAINE STANDARDS CO.	UC1 product codes 701au, 701bc, 701db, 701ri, 701ro, 701vt	2007-11-01
PMN K050504 | JJY MAINE STANDARDS CO.	OSMO product code 703	2007-11-01
PMN K041975 | JJY MAINE STANDARDS CO.	VALIDATE Lipoprotein 1 Calibration Verification Test Set	2007-11-01
PMN K041975 | JJY MAINE STANDARDS CO.	Lipoprotein 1 Calibration Verification Test Set	2007-11-01
PMN K041975 | JJY MAINE STANDARDS CO.	LP product codes 501ab, 501au, 501bc, 501db, 501ro, 501sa, 501vt	2007-11-01
PMN K033879 | DKB MAINE STANDARDS CO.	Validate TDM1 product code 301vt	2007-11-01
PMN K033879 | DKB MAINE STANDARDS CO.	Validate TDM1 product code 301ri	2007-11-01
PMN K033879 | DKB MAINE STANDARDS CO.	Validate TDM1 product code 301db	2007-11-01
PMN K033879 | DKB MAINE STANDARDS CO.	Validate TDM1 product code 301bc	2007-11-01
PMN K033879 | DKB MAINE STANDARDS CO.	Validate TDM1 product code 301au	2007-11-01
PMN K033879 | DKB MAINE STANDARDS CO.	Validate TDM1 product code 301ab	2007-11-01
PMN K033879 | DKB MAINE STANDARDS CO.	VALIDATE TDM1 Calibration Verification Test Set	2007-11-01
PMN K023410 | JJY MAINE STANDARDS CO.	VALIDATE Chem 10 Calibration Verification Test Set	2007-11-01
PMN K023352 | JJY MAINE STANDARDS CO.	VALIDATE Chem 9 Calibration Verification Test Set	2007-11-01
PMN K013119 | JJX MAINE STANDARDS CO.	VALIDATE Chem 6 Calibration Verification Test Set	2007-11-01
PMN K012122 | JJX MAINE STANDARDS CO.	VALIDATE Chem 5 Calibration Verification Test Set	2007-11-01
PMN K012120 | JJY MAINE STANDARDS CO.	Validate Chem 4 product code 104ab	2007-11-01
PMN K012120 | JJY MAINE STANDARDS CO.	VALIDATE Chem 4 Calibration Verification Test Set	2007-11-01
PMN K012120 | JJY MAINE STANDARDS CO.	MSC Chem 4 Calibration Verification Test Set	2007-11-01
PMN K012119 | JJY MAINE STANDARDS CO.	VALIDATE CHEM 3	2007-11-01
PMN K012118 | JJY MAINE STANDARDS CO.	VALIDATE Chem 2 Calibration Verification Test Set	2007-11-01
PMN K012117 | JJY MAINE STANDARDS CO.	VALIDATE Chem 17 Calibration Verification Test Set	2007-11-01
PMN K012117 | JJY MAINE STANDARDS CO.	VALIDATE Chem 1 Calibration Verification Test Set	2007-11-01
PMN K012117 | JJY MAINE STANDARDS CO.	Chem 1 Calibration Verification Test Set	2007-11-01
PMN K072246 MAINE STANDARDS CO.	VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601	2007-09-14
PMN K062501 MAINE STANDARDS CO.	VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901	2006-09-29
PMN K053247 MAINE STANDARDS CO.	VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET	2006-01-13
PMN K050504 MAINE STANDARDS CO.	VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS	2005-03-25
PMN K041975 MAINE STANDARDS CO.	VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501	2004-10-15
PMN K033879 MAINE STANDARDS CO.	VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126	2004-02-27
PMN K023410 MAINE STANDARDS CO.	VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110	2003-01-06
PMN K023352 MAINE STANDARDS CO.	VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109	2002-11-22
PMN K020450 MAINE STANDARDS CO.	VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108	2002-03-21
PMN K013265 MAINE STANDARDS CO.	VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007	2001-11-20
PMN K013119 MAINE STANDARDS CO.	VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006	2001-11-16
PMN K012122 MAINE STANDARDS CO.	VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005	2001-08-20
PMN K012120 MAINE STANDARDS CO.	VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004	2001-08-20
PMN K012119 MAINE STANDARDS CO.	VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003	2001-08-20
PMN K012118 MAINE STANDARDS CO.	VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002	2001-08-20
PMN K012117 MAINE STANDARDS CO.	VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001	2001-08-20

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