Medical Device Manufacturer · US , Abbott Park , IL

Abbott Laboratories Diagnostics Division - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 2019
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Abbott Laboratories Diagnostics Division Chemistry ✕
4 devices
1-4 of 4
Cleared Oct 16, 2024
Alkaline Phosphatase
K240468 · CJE
Chemistry · 239d
Cleared May 04, 2023
Alinity i STAT High Sensitivity Troponin-I
K230994 · MMI
Chemistry · 27d
Cleared May 19, 2022
Alinity i STAT High Sensitivity Troponin-I
K202525 · MMI
Chemistry · 625d
Cleared Sep 13, 2019
ARCHITECT STAT High Sensitivity Troponin-I
K191595 · MMI
Chemistry · 88d
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