Medical Device Manufacturer · US , La Vista , NE

Streck

32 submissions · 32 cleared · Since 2005
32
Total
32
Cleared
0
Denied

Streck — FDA 510(k) Submissions

Streck has submitted 32 FDA 510(k) premarket notifications since 2005, of which 32 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Mixture, Hematology Quality Control, Calibrator For Cell Indices, Mixture, Control, White-cell And Red-cell Indices, Urinalysis Controls (assayed And Unassayed), Assayed External Control Material For Microbiology Nucleic Acid Amplification (nat) Assays . Use the specialty filter in the sidebar to narrow results.

32 devices
1–25 of 32
MDx-Chex for BC-GP
K231221 · PMN Assayed External Control... · Microbiology
Jul 2023 90d
MDx-Chex for BC-GN
K231223 · PMN Assayed External Control... · Microbiology
Jul 2023 90d
UA-Cellular Complete
K170091 · JJW Urinalysis Controls... · Chemistry
Feb 2017 30d
XN CAL
K160585 · KRX Calibrator For Cell Indices · Hematology
Dec 2016 296d
XN-L CHECK
K160586 · JPK Mixture, Hematology... · Hematology
Dec 2016 296d
XN CHECK BF
K160588 · JPK Mixture, Hematology... · Hematology
Dec 2016 296d
XN CHECK
K160590 · JPK Mixture, Hematology... · Hematology
Dec 2016 296d
XN CAL PF
K141955 · KRX Calibrator For Cell Indices · Hematology
Dec 2014 140d
XN CHECK BF
K141957 · JPK Mixture, Hematology... · Hematology
Dec 2014 140d
XN CAL
K141962 · KRX Calibrator For Cell Indices · Hematology
Dec 2014 140d
XN CHECK
K141964 · JPK Mixture, Hematology... · Hematology
Dec 2014 140d
UA-CELLULAR COMPLETE
K131444 · JJW Urinalysis Controls... · Chemistry
Jan 2014 254d
XN CAL PF
K120747 · KRX Calibrator For Cell Indices · Hematology
Oct 2012 224d
XN CHECK
K120742 · JPK Mixture, Hematology... · Hematology
Oct 2012 221d
XN CHECK BF
K120744 · JPK Mixture, Hematology... · Hematology
Oct 2012 221d
XN CAL
K120745 · KRX Calibrator For Cell Indices · Hematology
Oct 2012 221d
CELL-DYN 22 PLUS CALIBRATOR
K111204 · KRX Calibrator For Cell Indices · Hematology
Dec 2011 237d
CELL-DYN 22 PLUS CONTROL
K111211 · GLQ Mixture, Control,... · Hematology
Dec 2011 237d
CELL-CHEX WITH CPPD CRYSTALS
K110718 · GLQ Mixture, Control,... · Hematology
May 2011 72d
CELL-CHEX
K101335 · GLQ Mixture, Control,... · Hematology
Aug 2010 103d
UA-CELLULAR FOR IQ
K090201 · JPK Mixture, Hematology... · Hematology
Mar 2009 59d
STAK-CHEX PLUS RETICS
K090137 · GLQ Mixture, Control,... · Hematology
Mar 2009 56d
CD4 COUNT
K083926 · GGL Control, White-cell · Hematology
Feb 2009 42d
X-CAL
K083200 · KRX Calibrator For Cell Indices · Hematology
Feb 2009 96d
CYTO-CHEX BCT
K080552 · GIM Tubes, Vacuum Sample,... · Hematology
Jul 2008 154d
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