Company ยท US
Streck
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2026. Name variants (Inc, Corp, punctuation) are merged.
38510(k) clearances (3 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JPK | Mixture, Hematology Quality Control | 12 |
| KRX | Calibrator For Cell Indices | 7 |
| PMN | Assayed External Control Material For Microbiology Nucleic Acid Amplification (Nat) Assays | 6 |
| GLQ | Mixture, Control, White-Cell And Red-Cell Indices | 4 |
| GGL | Control, White-Cell | 2 |
| GIM | Tubes, Vacuum Sample, With Anticoagulant | 2 |
| GJR | Control, Red-Cell | 2 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 2 |
| QMA | Blood Collection Device For Cell-Free Nucleic Acid | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 27, 2026 | K260041 | MDx-Chex for BCP Streck, LLC | PMN |
| Mar 23, 2026 | K254166 | MDx-Chex for BCN Streck | PMN |
| Mar 17, 2026 | K254167 | MDx-Chex for BCY Streck, LLC | PMN |
| Jul 26, 2024 | K231776 | Cell-Free DNA BCT Streck, Inc. | QMA |
| Jul 27, 2023 | K231223 | MDx-Chex for BC-GN Streck | PMN |
| Jul 27, 2023 | K231221 | MDx-Chex for BC-GP Streck | PMN |
| Jan 19, 2022 | K212576 | MDx-Chex for BCID2 Streck, Inc. | PMN |
| Aug 7, 2020 | DEN200001 | Cell-Free DNA BCT Streck, Inc. | QMA |
| Feb 9, 2017 | K170091 | UA-Cellular Complete Streck | JJW |
| Dec 22, 2016 | K160590 | XN CHECK Streck | JPK |
| Dec 22, 2016 | K160588 | XN CHECK BF Streck | JPK |
| Dec 22, 2016 | K160586 | XN-L CHECK Streck | JPK |
| Dec 22, 2016 | K160585 | XN CAL Streck | KRX |
| Dec 5, 2014 | K141964 | XN CHECK Streck | JPK |
| Dec 5, 2014 | K141962 | XN CAL Streck | KRX |
| Dec 5, 2014 | K141957 | XN CHECK BF Streck | JPK |
| Dec 5, 2014 | K141955 | XN CAL PF Streck | KRX |
| Jan 29, 2014 | K131444 | UA-CELLULAR COMPLETE Streck | JJW |
| Oct 22, 2012 | K120747 | XN CAL PF Streck | KRX |
| Oct 19, 2012 | K120745 | XN CAL Streck | KRX |
| Oct 19, 2012 | K120744 | XN CHECK BF Streck | JPK |
| Oct 19, 2012 | K120742 | XN CHECK Streck | JPK |
| Dec 22, 2011 | K111211 | CELL-DYN 22 PLUS CONTROL Streck | GLQ |
| Dec 22, 2011 | K111204 | CELL-DYN 22 PLUS CALIBRATOR Streck | KRX |
| May 26, 2011 | K110718 | CELL-CHEX WITH CPPD CRYSTALS Streck | GLQ |
| Aug 23, 2010 | K101335 | CELL-CHEX Streck | GLQ |
| Mar 27, 2009 | K090201 | UA-CELLULAR FOR IQ Streck | JPK |
| Mar 18, 2009 | K090137 | STAK-CHEX PLUS RETICS Streck | GLQ |
| Feb 11, 2009 | K083926 | CD4 COUNT Streck | GGL |
| Feb 3, 2009 | K083200 | X-CAL Streck | KRX |
| Jul 31, 2008 | K080552 | CYTO-CHEX BCT Streck | GIM |
| Feb 5, 2008 | K080016 | NRBC-CHEX FOR ADVIA Streck | GJR |
| Feb 23, 2007 | K070199 | RETIC-CHEX LINEARITY FOR BC Streck | JPK |
| Dec 14, 2006 | K063218 | E-CHECK (XE) Streck | JPK |
| Feb 9, 2006 | K060083 | NRBC-CHEX FOR LH Streck | GJR |
| Jan 13, 2006 | K053362 | CELL-CHEX AUTO Streck | JPK |
| Aug 17, 2005 | K051706 | IQ BODY FLUIDS CONTROL Streck | JPK |
| Aug 16, 2005 | K051633 | CD-CHEX PLUS BC Streck | GGL |