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Streck

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
35
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1684-2017Class IICyto-Chex BCT - blood specimen collection device - Immunophenotyping Preservative. IVD. Sterile. 2.0February 23, 2017

Recent 510(k) Clearances

K-NumberDeviceDate
K231776Cell-Free DNA BCTJuly 26, 2024
K231223MDx-Chex for BC-GNJuly 27, 2023
K231221MDx-Chex for BC-GPJuly 27, 2023
K212576MDx-Chex for BCID2January 19, 2022
DEN200001Cell-Free DNA BCTAugust 7, 2020
K170091UA-Cellular CompleteFebruary 9, 2017
K160588XN CHECK BFDecember 22, 2016
K160586XN-L CHECKDecember 22, 2016
K160590XN CHECKDecember 22, 2016
K160585XN CALDecember 22, 2016
K141955XN CAL PFDecember 5, 2014
K141962XN CALDecember 5, 2014
K141957XN CHECK BFDecember 5, 2014
K141964XN CHECKDecember 5, 2014
K131444UA-CELLULAR COMPLETEJanuary 29, 2014
K120747XN CAL PFOctober 22, 2012
K120744XN CHECK BFOctober 19, 2012
K120745XN CALOctober 19, 2012
K120742XN CHECKOctober 19, 2012
K111204CELL-DYN 22 PLUS CALIBRATORDecember 22, 2011