Streck

FDA Filings

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

Streck holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• DIESSE DIAGNOSTICA SENESE S.P.A

FDA Registration(s)

• Registration Number: 1950302
• FEI Number: 1950302
• Name: STRECK, Inc.
• Owner & Operator: STRECK
• Contact Address: 7002 SOUTH 109TH ST. --; La Vista NE 68128 US
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 7002 SOUTH 109TH ST. ; La Vista, NE 68128 US
• Establishment Type:
  • Manufacture Medical Device
  • Manufacture Medical Device for Another Party (Contract Manufacturer)
  • Manufacture Device in the United States for Export Only

FDA Filings

Device Company	Device	Date
PPM STRECK, Inc. [STRECK]	Cell-Free DNA Urine Preserve	2019-05-29
GGL STRECK, Inc. [STRECK]	ClearLLab Control Cells	2019-03-29
GIM STRECK, Inc. [STRECK]	Cell-Free DNA BCT CE	2018-10-23
PMN K143577 | JPK STRECK, Inc. [STRECK]	XW QC CHECK	2018-02-15
PMN K143577 | GKZ STRECK, Inc. [STRECK]	XW QC CHECK	2018-02-15
PMN K051706 | JPK STRECK, Inc. [STRECK]	Beckman Coulter iQ Body FLuids	2017-10-30
PMN K170091 | JJW STRECK, Inc. [STRECK]	UA-Cellular Complete	2017-02-17
PMN K170091 Streck	UA-Cellular Complete	2017-02-09
PMN K160590 | JPK STRECK, Inc. [STRECK]	XN CHECK	2017-01-20
PMN K160588 | JPK STRECK, Inc. [STRECK]	XN CHECK BF	2017-01-20
PMN K160586 | JPK STRECK, Inc. [STRECK]	XN-L CHECK	2017-01-20
PMN K160585 | KRX STRECK, Inc. [STRECK]	XN CAL	2017-01-20
KFC STRECK, Inc. [STRECK]	Retic-Chex Stain	2017-01-20
PMN K160590 STRECK	XN CHECK	2016-12-22
PMN K160588 STRECK	XN CHECK BF	2016-12-22
PMN K160586 STRECK	XN-L CHECK	2016-12-22
PMN K160585 Streck	XN CAL	2016-12-22
KRX STRECK, Inc. [STRECK]	Alinity h-series HemCal	2016-12-13
JPK STRECK, Inc. [STRECK]	Alinity h-series Control 29P	2016-12-13
GHC STRECK, Inc. [STRECK]	ESR Vacuum Tubes	2015-10-05
GHC STRECK, Inc. [STRECK]	ESR Vacuum Tubes Safety Coated	2015-10-05
GHC STRECK, Inc. [STRECK]	ESR Vacuum Tubes High Altitude	2015-10-05
PMN K041240 | NRF STRECK, Inc. [STRECK]	Sperm-Chex	2015-08-19
PMN K041240 | NRF STRECK, Inc. [STRECK]	Sperm-Chex Post VC	2015-08-19
LEA STRECK, Inc. [STRECK]	Streck Cell Preservative	2015-06-18
PMN K141964 | JPK STRECK, Inc. [STRECK]	XN CHECK	2014-12-23
PMN K141962 | KRX STRECK, Inc. [STRECK]	XN CAL	2014-12-23
PMN K141957 | JPK STRECK, Inc. [STRECK]	XN CHECK BF	2014-12-23
PMN K141955 | KRX STRECK, Inc. [STRECK]	XN CAL PF	2014-12-23
PMN K141964 Streck	XN CHECK	2014-12-05
PMN K141962 Streck	XN CAL	2014-12-05
PMN K141957 Streck	XN CHECK BF	2014-12-05
PMN K141955 Streck	XN CAL PF	2014-12-05
PMN K131444 | JJW STRECK, Inc. [STRECK]	UA-Cellular Complete	2014-02-14
PMN K131444 Streck	UA-CELLULAR COMPLETE	2014-01-29
PMN K101335 | GLQ STRECK, Inc. [STRECK]	Cell-Chex	2013-09-03
PMN K022968 | JPK STRECK, Inc. [STRECK]	TESTpoint CSF Controls (2 x 3 mL)	2013-01-30
PMN K022331 | JPK STRECK, Inc. [STRECK]	CSF Reagent (1 x 8 mL)	2013-01-30
PMN K022331 | GKZ STRECK, Inc. [STRECK]	CSF Reagent (1 x 8 mL)	2013-01-30
PMN K022331 | GKL STRECK, Inc. [STRECK]	CSF Reagent (1 x 8 mL)	2013-01-30
PMN K080552 | GIM STRECK, Inc. [STRECK]	Cyto-Chex BCT	2013-01-21
OUL STRECK, Inc. [STRECK]	Philisa Thermal Cycler	2012-11-26
PMN K120747 | KRX STRECK, Inc. [STRECK]	XN CAL PF	2012-11-01
PMN K120745 | KRX STRECK, Inc. [STRECK]	XN CAL	2012-11-01
PMN K120744 | JPK STRECK, Inc. [STRECK]	XN CHECK BF	2012-11-01
PMN K120742 | JPK STRECK, Inc. [STRECK]	XN CHECK	2012-11-01
PMN K120747 Streck	XN CAL PF	2012-10-22
PMN K120745 Streck	XN CAL	2012-10-19
PMN K120744 Streck	XN CHECK BF	2012-10-19
PMN K120742 Streck	XN CHECK	2012-10-19
PMN K111211 | GLQ STRECK, Inc. [STRECK]	CELL-DYN 22 Plus Control	2012-02-15
PMN K111204 | KRX STRECK, Inc. [STRECK]	CELL-DYN 22 Plus Calibrator	2012-02-15
PMN K111211 Streck	CELL-DYN 22 PLUS CONTROL	2011-12-22
PMN K111204 Streck	CELL-DYN 22 PLUS CALIBRATOR	2011-12-22
PMN K110718 Streck	CELL-CHEX WITH CPPD CRYSTALS	2011-05-26
PMN K101335 Streck	CELL-CHEX	2010-08-23
PMN K993825 | JCN STRECK, Inc. [STRECK]	3-in-1 TESTpoint Hematology Normal Control (4 x 4 mL)	2010-04-05
PMN K993825 | JCN STRECK, Inc. [STRECK]	3-in-1 TESTpoint Hematology Abnormal Control 2 (4 x 4 mL)	2010-04-05
PMN K993825 | JCN STRECK, Inc. [STRECK]	3-in-1 TESTpoint Hematology Abnormal Control 1 (4 x 4 mL)	2010-04-05
PMN K905524 | JPK STRECK, Inc. [STRECK]	TESTpoint Retic Low Control (4 x 4 mL)	2010-04-05
PMN K905524 | JPK STRECK, Inc. [STRECK]	TESTpoint Retic High Control (4 x 4 mL)	2010-04-05
PMN K913687 | JJY STRECK, Inc. [STRECK]	Roche Accutrend Cholesterol Control	2009-10-27
PMN K042587 | JPK STRECK, Inc. [STRECK]	Retic-Chex for CELL-DYN	2009-05-28
PMN K042587 | JPK STRECK, Inc. [STRECK]	CELL-DYN Retic Plus Control	2009-05-28
PMN K090201 | JPK STRECK, Inc. [STRECK]	UA-Cellular for IQ	2009-04-03
PMN K090201 Streck	UA-CELLULAR FOR IQ	2009-03-27
PMN K090137 | GLQ STRECK, Inc. [STRECK]	STaK-Chex Plus Retics	2009-03-26
PMN K090137 Streck	STAK-CHEX PLUS RETICS	2009-03-18
PMN K083200 | KRX STRECK, Inc. [STRECK]	X-Cal	2009-02-11
PMN K083200 Streck	X-CAL	2009-02-03
PMN K994388 | JPK STRECK, Inc. [STRECK]	Sysmex e-CHECK	2009-02-02
PMN K994388 | JPK STRECK, Inc. [STRECK]	Sysmex e-CHECK XS	2009-02-02
PMN K994388 | GLQ STRECK, Inc. [STRECK]	Sysmex e-CHECK	2009-02-02
PMN K994388 | GLQ STRECK, Inc. [STRECK]	Sysmex e-CHECK XS	2009-02-02
PMN K943268 | KSA STRECK, Inc. [STRECK]	Sysmex SCS-1000 Hematology Calibrator	2009-02-02
PMN K063218 | JPK STRECK, Inc. [STRECK]	Sysmex e-CHECK XE	2009-02-02
PMN K823498 | GLQ STRECK, Inc. [STRECK]	Para 12	2008-09-08
PMN K823498 | GLQ STRECK, Inc. [STRECK]	Para 12 Extend	2008-09-08
PMN K823498 | GLQ STRECK, Inc. [STRECK]	CELL-DYN 18 Plus Control	2008-09-08
PMN K080552 Streck	CYTO-CHEX BCT	2008-07-31
PMN K080016 Streck	NRBC-CHEX FOR ADVIA	2008-02-05
PMN K993126 | GGL STRECK, Inc. [STRECK]	CD-Chex CD34	2007-10-31
PMN K992887 | GLQ STRECK, Inc. [STRECK]	STaK-Chex Plus Retics	2007-10-31
PMN K960894 | GGL STRECK, Inc. [STRECK]	CD-Chex Plus	2007-10-31
PMN K960894 | GGL STRECK, Inc. [STRECK]	CD-Chex Plus CD4 Low	2007-10-31
PMN K960557 | JPK STRECK, Inc. [STRECK]	WRP CHECK	2007-10-31
PMN K960557 | JPK STRECK, Inc. [STRECK]	WRP CHECK EX	2007-10-31
PMN K960557 | JPK STRECK, Inc. [STRECK]	Sysmex RANGE CHECK X III	2007-10-31
PMN K960557 | JPK STRECK, Inc. [STRECK]	Sysmex RANGE CHECK X II	2007-10-31
PMN K960557 | JPK STRECK, Inc. [STRECK]	Sysmex Plt-CHECK	2007-10-31
PMN K960557 | JPK STRECK, Inc. [STRECK]	CVA	2007-10-31
PMN K960557 | JPK STRECK, Inc. [STRECK]	CVA for CELL-DYN	2007-10-31
PMN K933844 | JJY STRECK, Inc. [STRECK]	Para 4 Plus	2007-10-31
PMN K933844 | JJY STRECK, Inc. [STRECK]	HQ-Chex	2007-10-31
PMN K911582 | JCN STRECK, Inc. [STRECK]	STaK-Chex	2007-10-31
PMN K901875 | JCN STRECK, Inc. [STRECK]	Para 12 Plus	2007-10-31
PMN K901875 | JCN STRECK, Inc. [STRECK]	CELL-DYN 26 Plus Control	2007-10-31
PMN K896154 | JCN STRECK, Inc. [STRECK]	TESTpoint Hematology Normal Control (4 x 4 mL)	2007-10-31
PMN K896154 | JCN STRECK, Inc. [STRECK]	TESTpoint Hematology Low Control (4 x 4 mL)	2007-10-31
PMN K896154 | JCN STRECK, Inc. [STRECK]	TESTpoint Hematology High Control (4 x 4 mL)	2007-10-31
PMN K896154 | JCN STRECK, Inc. [STRECK]	Para Tech	2007-10-31
PMN K852992 | JPK STRECK, Inc. [STRECK]	Para Check	2007-10-31
PMN K852992 | JPK STRECK, Inc. [STRECK]	EIGHTCHECK-3WP	2007-10-31
PMN K852992 | JPK STRECK, Inc. [STRECK]	EIGHTCHECK-3WP X-TRA	2007-10-31
PMN K851043 | JJX STRECK, Inc. [STRECK]	Sugar-Chex II	2007-10-31
PMN K851043 | JJX STRECK, Inc. [STRECK]	Roche AT Sensor Comfort Control	2007-10-31
PMN K842017 | JPK STRECK, Inc. [STRECK]	Para 4	2007-10-31
PMN K840261 | KRZ STRECK, Inc. [STRECK]	SETpoint Hematology Calibrator (2 x 6.1 mL)	2007-10-31
PMN K840261 | KRZ STRECK, Inc. [STRECK]	Cal-Chex	2007-10-31
PMN K840261 | KRZ STRECK, Inc. [STRECK]	Cal-Chex H	2007-10-31
PMN K840261 | KRZ STRECK, Inc. [STRECK]	CELL-DYN 18 Plus Calibrator	2007-10-31
PMN K070199 | JPK STRECK, Inc. [STRECK]	Retic-Chex Linearity for BC	2007-10-31
PMN K053362 | JPK STRECK, Inc. [STRECK]	Cell-Chex Auto	2007-10-31
PMN K051633 | GGL STRECK, Inc. [STRECK]	CD-Chex Plus BC	2007-10-31
PMN K051633 | GGL STRECK, Inc. [STRECK]	CD-Chex Plus BC CD4 Low	2007-10-31
PMN K040025 | JJX STRECK, Inc. [STRECK]	A1c-Cellular	2007-10-31
PMN K040025 | JJX STRECK, Inc. [STRECK]	A1c-Cellular Linearity	2007-10-31
PMN K023656 | GHM STRECK, Inc. [STRECK]	SICKLEDEX	2007-10-31
PMN K020469 | KSA STRECK, Inc. [STRECK]	Cal-Chex A Plus	2007-10-31
PMN K020469 | KSA STRECK, Inc. [STRECK]	CELL-DYN HemCal Plus	2007-10-31
PMN K020469 | KRZ STRECK, Inc. [STRECK]	Cal-Chex A Plus	2007-10-31
PMN K020469 | KRZ STRECK, Inc. [STRECK]	CELL-DYN HemCal Plus	2007-10-31
PMN K020469 | KRY STRECK, Inc. [STRECK]	Cal-Chex A Plus	2007-10-31
PMN K020469 | KRY STRECK, Inc. [STRECK]	CELL-DYN HemCal Plus	2007-10-31
PMN K020469 | KRX STRECK, Inc. [STRECK]	Cal-Chex A Plus	2007-10-31
PMN K020469 | KRX STRECK, Inc. [STRECK]	CELL-DYN HemCal Plus	2007-10-31
PMN K013316 | GHM STRECK, Inc. [STRECK]	Sickle-Chex	2007-10-31
PMN K000945 | GLQ STRECK, Inc. [STRECK]	Para 12 Plus Retics	2007-10-31
PMN K000945 | GLQ STRECK, Inc. [STRECK]	CELL-DYN 29 Plus Control (w/Retics)	2007-10-31
PMN K000115 | JPK STRECK, Inc. [STRECK]	Retic-Chex II	2007-10-31
PMN K070199 Streck	RETIC-CHEX LINEARITY FOR BC	2007-02-23
PMN K063218 Streck	E-CHECK (XE)	2006-12-14
PMN K060083 Streck	NRBC-CHEX FOR LH	2006-02-09
PMN K053362 Streck	CELL-CHEX AUTO	2006-01-13
PMN K051706 Streck	IQ BODY FLUIDS CONTROL	2005-08-17
PMN K051633 Streck	CD-CHEX PLUS BC	2005-08-16
GKB STRECK, Inc. [STRECK]	ESR-Auto Plus	2003-08-13
GKB STRECK, Inc. [STRECK]	ESR-10 Manual Rack	2003-08-13
JPH STRECK, Inc. [STRECK]	ESR-CHEX	1997-05-28
JPH STRECK, Inc. [STRECK]	ESR-CHEX PLUS	1997-05-28
KDT STRECK, Inc. [STRECK]	MULTIPLE PRODUCTS	1995-02-14

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