Streck Inc

FDA Filings

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

FDA Registration(s)
Registration Number1950302
FEI Number1950302
NameSTRECK, Inc.
Owner & OperatorSTRECK
Contact Address7002 SOUTH 109TH ST. --
La Vista NE 68128 US
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address7002 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
DeviceDate
STRECK, INC.
 CD-Chex Plus 2133302023-11-20
STRECK, INC.
 CD-Chex Plus 2133252023-11-20
STRECK, INC.
 MDx-Chex for BC-GP 2500792023-08-17
STRECK, INC.
 MDx-Chex for BC-GN 2500802023-08-17
STRECK, INC.
 Streck Viral Extraction Kit 2500742023-06-21
STRECK, INC.
 MDx-Chex for BCID2 2500652022-02-02
Streck, Inc
MDx-Chex For BCID22022-01-19
STRECK, INC.
 Para 12® Plus 2305922020-09-01
STRECK, INC.
 Cell-Free DNA BCT 2304712020-08-18
Streck, Inc.
Cell-Free DNA BCT2020-08-07
Streck, Inc.
Otc Medication2020-03-31
Streck, Inc.
Streck Antiseptic Hand Rub2020-03-30
STRECK, Inc. [STRECK]
Cell-Free DNA Urine Preserve2019-05-29
STRECK, Inc. [STRECK]
ClearLLab Control Cells2019-03-29
STRECK, Inc. [STRECK]
Cell-Free DNA BCT CE2018-10-23
STRECK, INC.
 Para 12 Extend 2187522018-07-06
STRECK, INC.
 Cyto-Chex BCT 2303532018-07-06
STRECK, INC.
 Cyto-Chex® BCT 2303772018-07-06
STRECK, INC.
 Para 4 2154362018-07-06
STRECK, INC.
 Para 4 2154162018-07-06
STRECK, INC.
 Para 4 2154262018-07-06
STRECK, INC.
 Para 12 Extend 2187532018-07-06
STRECK, INC.
 Para 12 Extend 2187512018-07-06
STRECK, INC.
 Para 12 Extend 2189952018-07-06
STRECK, INC.
 CD-Chex Plus BC 2133772018-07-06
STRECK, INC.
 CD-Chex Plus BC 2133782018-07-06
STRECK, INC.
 Cal-Chex A Plus 2211082018-07-06
STRECK, INC.
 CD-Chex Plus 2133242018-07-06
STRECK, INC.
 CD-Chex Plus 2133232018-07-06
STRECK, INC.
 CD-Chex Plus 2133332018-07-06
STRECK, INC.
 Cyto-Chex BCT 2303062018-07-06
STRECK, INC.
 STaK-Chex 2255142018-07-06
STRECK, INC.
 Cyto-Chex® BCT 2303762018-07-06
STRECK, INC.
 Cyto-Chex BCT 2133862018-07-06
STRECK, INC.
 Para 4 2151082018-07-06
STRECK, INC.
 Para 4 2151072018-07-06
STRECK, INC.
 Para 4 2151062018-07-06
STRECK, INC.
 Para 12 Extend 2189942018-07-06
STRECK, INC.
 Para 12 Extend 2189932018-07-06
STRECK, INC.
 Para 12 Extend 2187582018-07-06
STRECK, INC.
 CD-Chex Plus BC 2133722018-07-06
STRECK, INC.
 CD-Chex Plus BC 2133742018-07-06
STRECK, INC.
 CD-Chex CD34 2133832018-07-06
STRECK, INC.
 CD-Chex CD34 2133472018-07-06
STRECK, INC.
 CD-Chex CD34 2133372018-07-06
STRECK, INC.
 STaK-Chex Plus Retics 2254832018-07-06
STRECK, INC.
 Cal-Chex A Plus 2211072018-07-06
STRECK, INC.
 Cell-Chex 2124302018-07-06
STRECK, INC.
 Cal-Chex 2211032018-07-06
STRECK, INC.
 CD-Chex Plus 2133682018-07-06
STRECK, INC.
 CD-Chex Plus 2133672018-07-06
STRECK, INC.
 CD-Chex Plus 2133322018-07-06
STRECK, INC.
 CD-Chex Plus 2133272018-07-06
STRECK, INC.
 Cyto-Chex BCT 2303052018-07-06
STRECK, INC.
 HQ-Chex 2327552018-07-06
STRECK, INC.
 HQ-Chex 2327542018-07-06
STRECK, INC.
 HQ-Chex 2327532018-07-06
STRECK, INC.
 STaK-Chex 2255342018-07-06
STRECK, INC.
 STaK-Chex 2251142018-07-06
STRECK, INC.
 STaK-Chex 2255242018-07-06
STRECK, INC.
 Cyto-Chex BCT 2189802018-07-06
STRECK, INC.
 Cyto-Chex BCT 2133622018-07-06
STRECK, INC.
 Cell-Chex Auto 2000692018-07-06
STRECK, INC.
 Cell-Chex Auto 2000682018-07-06
STRECK, INC.
 Cell-Chex Auto 2000672018-07-06
STRECK, INC.
 CD-Chex Plus BC 2133712018-07-06
STRECK, INC.
 CD-Chex Plus BC 2133732018-07-06
STRECK, INC.
 CD-Chex CD34 2133822018-07-06
STRECK, INC.
 CD-Chex CD34 2133462018-07-06
STRECK, INC.
 CD-Chex CD34 2133362018-07-06
STRECK, INC.
 STaK-Chex Plus Retics 2254822018-07-06
STRECK, INC.
 STaK-Chex Plus Retics 2254812018-07-06
STRECK, INC.
 STaK-Chex Plus Retics 2254802018-07-06
STRECK, INC.
 Cal-Chex A Plus 2211062018-07-06
STRECK, INC.
 Cell-Chex 2124242018-07-06
STRECK, INC.
 Cell-Chex 2124292018-07-06
STRECK, INC.
 Cell-Chex 2124322018-07-06
STRECK, INC.
 Cal-Chex 2211012018-07-06
STRECK, INC.
 Para 12 Plus 2189342018-07-06
STRECK, INC.
 Para 12 Plus 2189142018-07-06
STRECK, INC.
 Para 12 Plus 2189242018-07-06
STRECK, INC.
 CD-Chex Plus 2133662018-07-06
STRECK, INC.
 CD-Chex Plus 2133652018-07-06
STRECK, INC.
 CD-Chex Plus 2133312018-07-06
STRECK, INC.
 CD-Chex Plus 2133262018-07-06
STRECK, INC.
 Para 12 Extend 2187502018-07-06
STRECK, INC.
 Cell-Chex Auto 2134792018-07-06
STRECK, INC.
 Cell-Chex Auto 2000662018-07-06
STRECK, INC.
 Cell-Chex Auto 2000652018-07-06
STRECK, INC.
 CD-Chex Plus BC 2133762018-07-06
STRECK, INC.
 CD-Chex Plus BC 2133752018-07-06
STRECK, INC.
 CD-Chex CD34 2133392018-07-06
STRECK, INC.
 CD-Chex CD34 2133382018-07-06
STRECK, INC.
 STaK-Chex Plus Retics 2254892018-07-06
STRECK, INC.
 STaK-Chex Plus Retics 2254852018-07-06
STRECK, INC.
 Cell-Chex 2124312018-07-06
STRECK, INC.
 Cell-Chex 2124252018-07-06
STRECK, INC.
 Cell-Chex 2124202018-07-06
STRECK, INC.
 Para 12 Plus 2189132018-07-06
STRECK, INC.
 Para 12 Plus 2189072018-07-06
STRECK, INC.
 Para 12 Plus 2189032018-07-06
STRECK, INC.
 CD-Chex Plus 2133912018-07-06
STRECK, INC.
 CD-Chex Plus 2133702018-07-06
STRECK, INC.
 CD-Chex Plus 2133692018-07-06
STRECK, INC.
 CD-Chex Plus 2133442018-07-06
STRECK, INC.
 CD-Chex Plus 2133412018-07-06
STRECK, INC.
 CD-Chex Plus 2133402018-07-06
STRECK, Inc. [STRECK]
XW QC CHECK2018-02-15
STRECK, Inc. [STRECK]
XW QC CHECK2018-02-15
STRECK, Inc. [STRECK]
Beckman Coulter iQ Body FLuids2017-10-30
STRECK, Inc. [STRECK]
UA-Cellular Complete2017-02-17
STRECK, Inc. [STRECK]
XN CHECK2017-01-20
STRECK, Inc. [STRECK]
XN CHECK BF2017-01-20
STRECK, Inc. [STRECK]
XN-L CHECK2017-01-20
STRECK, Inc. [STRECK]
XN CAL2017-01-20
STRECK, Inc. [STRECK]
Retic-Chex Stain2017-01-20
STRECK, Inc. [STRECK]
Alinity h-series HemCal2016-12-13
STRECK, Inc. [STRECK]
Alinity h-series Control 29P2016-12-13
STRECK, Inc. [STRECK]
ESR Vacuum Tubes2015-10-05
STRECK, Inc. [STRECK]
ESR Vacuum Tubes Safety Coated2015-10-05
STRECK, Inc. [STRECK]
ESR Vacuum Tubes High Altitude2015-10-05
STRECK, Inc. [STRECK]
Sperm-Chex2015-08-19
STRECK, Inc. [STRECK]
Sperm-Chex Post VC2015-08-19
STRECK, Inc. [STRECK]
Streck Cell Preservative2015-06-18
STRECK, Inc. [STRECK]
XN CHECK2014-12-23
STRECK, Inc. [STRECK]
XN CAL2014-12-23
STRECK, Inc. [STRECK]
XN CHECK BF2014-12-23
STRECK, Inc. [STRECK]
XN CAL PF2014-12-23
STRECK, Inc. [STRECK]
UA-Cellular Complete2014-02-14
STRECK, Inc. [STRECK]
Cell-Chex2013-09-03
STRECK, Inc. [STRECK]
TESTpoint CSF Controls (2 x 3 mL)2013-01-30
STRECK, Inc. [STRECK]
CSF Reagent (1 x 8 mL)2013-01-30
STRECK, Inc. [STRECK]
CSF Reagent (1 x 8 mL)2013-01-30
STRECK, Inc. [STRECK]
CSF Reagent (1 x 8 mL)2013-01-30
STRECK, Inc. [STRECK]
Cyto-Chex BCT2013-01-21
STRECK, Inc. [STRECK]
Philisa Thermal Cycler2012-11-26
STRECK, Inc. [STRECK]
XN CAL PF2012-11-01
STRECK, Inc. [STRECK]
XN CAL2012-11-01
STRECK, Inc. [STRECK]
XN CHECK BF2012-11-01
STRECK, Inc. [STRECK]
XN CHECK2012-11-01
STRECK, Inc. [STRECK]
CELL-DYN 22 Plus Control2012-02-15
STRECK, Inc. [STRECK]
CELL-DYN 22 Plus Calibrator2012-02-15
STRECK, Inc. [STRECK]
3-in-1 TESTpoint Hematology Normal Control (4 x 4 mL)2010-04-05
STRECK, Inc. [STRECK]
3-in-1 TESTpoint Hematology Abnormal Control 2 (4 x 4 mL)2010-04-05
STRECK, Inc. [STRECK]
3-in-1 TESTpoint Hematology Abnormal Control 1 (4 x 4 mL)2010-04-05
STRECK, Inc. [STRECK]
TESTpoint Retic Low Control (4 x 4 mL)2010-04-05
STRECK, Inc. [STRECK]
TESTpoint Retic High Control (4 x 4 mL)2010-04-05
STRECK, Inc. [STRECK]
Roche Accutrend Cholesterol Control2009-10-27
STRECK, Inc. [STRECK]
Retic-Chex for CELL-DYN2009-05-28
STRECK, Inc. [STRECK]
CELL-DYN Retic Plus Control2009-05-28
STRECK, Inc. [STRECK]
UA-Cellular for IQ2009-04-03
STRECK, Inc. [STRECK]
STaK-Chex Plus Retics2009-03-26
STRECK, Inc. [STRECK]
X-Cal2009-02-11
STRECK, Inc. [STRECK]
Sysmex e-CHECK2009-02-02
STRECK, Inc. [STRECK]
Sysmex e-CHECK XS2009-02-02
STRECK, Inc. [STRECK]
Sysmex e-CHECK2009-02-02
STRECK, Inc. [STRECK]
Sysmex e-CHECK XS2009-02-02
STRECK, Inc. [STRECK]
Sysmex SCS-1000 Hematology Calibrator2009-02-02
STRECK, Inc. [STRECK]
Sysmex e-CHECK XE2009-02-02
STRECK, Inc. [STRECK]
Para 122008-09-08
STRECK, Inc. [STRECK]
Para 12 Extend2008-09-08
STRECK, Inc. [STRECK]
CELL-DYN 18 Plus Control2008-09-08
STRECK, Inc. [STRECK]
CD-Chex CD342007-10-31
STRECK, Inc. [STRECK]
STaK-Chex Plus Retics2007-10-31
STRECK, Inc. [STRECK]
CD-Chex Plus2007-10-31
STRECK, Inc. [STRECK]
CD-Chex Plus CD4 Low2007-10-31
STRECK, Inc. [STRECK]
WRP CHECK2007-10-31
STRECK, Inc. [STRECK]
WRP CHECK EX2007-10-31
STRECK, Inc. [STRECK]
Sysmex RANGE CHECK X III2007-10-31
STRECK, Inc. [STRECK]
Sysmex RANGE CHECK X II2007-10-31
STRECK, Inc. [STRECK]
Sysmex Plt-CHECK2007-10-31
STRECK, Inc. [STRECK]
CVA2007-10-31
STRECK, Inc. [STRECK]
CVA for CELL-DYN2007-10-31
STRECK, Inc. [STRECK]
Para 4 Plus2007-10-31
STRECK, Inc. [STRECK]
HQ-Chex2007-10-31
STRECK, Inc. [STRECK]
STaK-Chex2007-10-31
STRECK, Inc. [STRECK]
Para 12 Plus2007-10-31
STRECK, Inc. [STRECK]
CELL-DYN 26 Plus Control2007-10-31
STRECK, Inc. [STRECK]
TESTpoint Hematology Normal Control (4 x 4 mL)2007-10-31
STRECK, Inc. [STRECK]
TESTpoint Hematology Low Control (4 x 4 mL)2007-10-31
STRECK, Inc. [STRECK]
TESTpoint Hematology High Control (4 x 4 mL)2007-10-31
STRECK, Inc. [STRECK]
Para Tech2007-10-31
STRECK, Inc. [STRECK]
Para Check2007-10-31
STRECK, Inc. [STRECK]
EIGHTCHECK-3WP2007-10-31
STRECK, Inc. [STRECK]
EIGHTCHECK-3WP X-TRA2007-10-31
STRECK, Inc. [STRECK]
Sugar-Chex II2007-10-31
STRECK, Inc. [STRECK]
Roche AT Sensor Comfort Control2007-10-31
STRECK, Inc. [STRECK]
Para 42007-10-31
STRECK, Inc. [STRECK]
SETpoint Hematology Calibrator (2 x 6.1 mL)2007-10-31
STRECK, Inc. [STRECK]
Cal-Chex2007-10-31
STRECK, Inc. [STRECK]
Cal-Chex H2007-10-31
STRECK, Inc. [STRECK]
CELL-DYN 18 Plus Calibrator2007-10-31
STRECK, Inc. [STRECK]
Retic-Chex Linearity for BC2007-10-31
STRECK, Inc. [STRECK]
Cell-Chex Auto2007-10-31
STRECK, Inc. [STRECK]
CD-Chex Plus BC2007-10-31
STRECK, Inc. [STRECK]
CD-Chex Plus BC CD4 Low2007-10-31
STRECK, Inc. [STRECK]
A1c-Cellular2007-10-31
STRECK, Inc. [STRECK]
A1c-Cellular Linearity2007-10-31
STRECK, Inc. [STRECK]
SICKLEDEX2007-10-31
STRECK, Inc. [STRECK]
Cal-Chex A Plus2007-10-31
STRECK, Inc. [STRECK]
CELL-DYN HemCal Plus2007-10-31
STRECK, Inc. [STRECK]
Cal-Chex A Plus2007-10-31
STRECK, Inc. [STRECK]
CELL-DYN HemCal Plus2007-10-31
STRECK, Inc. [STRECK]
Cal-Chex A Plus2007-10-31
STRECK, Inc. [STRECK]
CELL-DYN HemCal Plus2007-10-31
STRECK, Inc. [STRECK]
Cal-Chex A Plus2007-10-31
STRECK, Inc. [STRECK]
CELL-DYN HemCal Plus2007-10-31
STRECK, Inc. [STRECK]
Sickle-Chex2007-10-31
STRECK, Inc. [STRECK]
Para 12 Plus Retics2007-10-31
STRECK, Inc. [STRECK]
CELL-DYN 29 Plus Control (w/Retics)2007-10-31
STRECK, Inc. [STRECK]
Retic-Chex II2007-10-31
STRECK, Inc. [STRECK]
ESR-Auto Plus2003-08-13
STRECK, Inc. [STRECK]
ESR-10 Manual Rack2003-08-13
STRECK, Inc. [STRECK]
ESR-CHEX1997-05-28
STRECK, Inc. [STRECK]
ESR-CHEX PLUS1997-05-28
STRECK, Inc. [STRECK]
MULTIPLE PRODUCTS1995-02-14

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