Medical Device Manufacturer · US , La Vista , NE

Streck - FDA 510(k) Cleared Devices

33 submissions · 33 cleared · Since 2005

Recent clearances: MDx-Chex for BCN, MDx-Chex for BC-GP, MDx-Chex for BC-GN

33
Total
33
Cleared
0
Denied

FDA 510(k) Regulatory Record - Streck Hematology ✕

28 devices
1-12 of 28
Cleared Dec 22, 2016
XN CAL
K160585 · KRX
Hematology · 296d
Cleared Dec 22, 2016
XN-L CHECK
K160586 · JPK
Hematology · 296d
Cleared Dec 22, 2016
XN CHECK BF
K160588 · JPK
Hematology · 296d
Cleared Dec 22, 2016
XN CHECK
K160590 · JPK
Hematology · 296d
Cleared Dec 05, 2014
XN CAL PF
K141955 · KRX
Hematology · 140d
Cleared Dec 05, 2014
XN CHECK BF
K141957 · JPK
Hematology · 140d
Cleared Dec 05, 2014
XN CAL
K141962 · KRX
Hematology · 140d
Cleared Dec 05, 2014
XN CHECK
K141964 · JPK
Hematology · 140d
Cleared Oct 22, 2012
XN CAL PF
K120747 · KRX
Hematology · 224d
Cleared Oct 19, 2012
XN CHECK
K120742 · JPK
Hematology · 221d
Cleared Oct 19, 2012
XN CHECK BF
K120744 · JPK
Hematology · 221d
Cleared Oct 19, 2012
XN CAL
K120745 · KRX
Hematology · 221d
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