MAINE STANDARDS CO.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
1226774	3003407015	MAINE STANDARDS CO.	1	N	2020-04-25	221 US Route 1 Cumb Foreside ME US 04110

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
59193	1891602059	K170864	VALIDATE D-Dimer Calibration Verification / Linearity Test Kit	GGN	2017-06-21
59193	1430930264	K163498	VALIDATE Heparin Calibration Verification/Linearity Test Kit	GGN	2017-03-16
59193	1037911617	K162705	VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit	GGN	2017-01-05
59193	1645838294	K152961	VALIDATE D-Dimer Calibration Verification/Linearity Test Kit	GGN	2016-06-03
59193	1523435635	K142964	VALIDATE Anemia Calibration Verification/ Linearity Test Kit	JJY	2015-04-30
59193	1332523798	K133550	VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT	JJX	2014-02-05
59193	1918569539	K123127	VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406	JJX	2013-06-14
59193	1659975016	K113524	VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT	JJX	2012-01-27
59193	1305928398	K110880	VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT	JJY	2011-07-05
59193	1842415025	K103271	MSC LIPID CONTROL	JJY	2011-01-25
59193	1102760728	K091225	VALIDATE GC1, GC2, GC3 AND GC4 CALIBRATION VERIFICATION/LINEARITY TEST SET	JJY	2009-06-25
59193	1918137270	K090475	VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402	JJY	2009-04-16
59193	1046725158	K083891	VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901	JJY	2009-03-23
59193	1594981369	K082067	MSC LIPID CONTROL	JJY	2008-08-22
59193	1419677351	K072246	VALIDATE SP1 CALIBRATION VERIFICATION/LINEARITY TEST SET, MODEL 601	JJY	2007-09-14
59193	1820732792	K062501	VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901	JJX	2006-09-29
59193	1409980369	K053247	VALIDATE CARDIAC MARKER (CM1) CALIBRATION VERIFICATION TEST SET	JJY	2006-01-13
59193	1485258221	K050504	VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS	JJY	2005-03-25
59193	1646398886	K041975	VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501	JJY	2004-10-15
59193	2052179991	K033879	VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126	DKB	2004-02-27
59193	1383755605	K023410	VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110	JJY	2003-01-06
59193	1756836329	K023352	VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109	JJY	2002-11-22
59193	1740598720	K020450	VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108	JJY	2002-03-21
59193	1631127047	K013265	VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007	JJY	2001-11-20
59193	1623701680	K013119	VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006	JJX	2001-11-16
59193	1273160030	K012122	VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005	JJX	2001-08-20
59193	1054467637	K012120	VALIDATE CHEM 4 CALIBRATION VERIFICATION TEST SET, MODEL 10004	JJY	2001-08-20
59193	1786121630	K012119	VALIDATE CHEM 3 CALIBRATION VERIFICATION TEST SET, MODEL 10003	JJY	2001-08-20
59193	1442580289	K012118	VALIDATE CHEM 2 CALIBRATION VERIFICATION TEST SET, MODEL 10002	JJY	2001-08-20
59193	1493122882	K012117	VALIDATE CHEM 1 CALIBRATION VERIFICATION TEST SET, MODEL 10001	JJY	2001-08-20
59193	1004087635
59193	1065349518
59193	1236501005
59193	1242493936
59193	1762690026
59193	1825353387