Medical Device Manufacturer · US , Roswell , GA

Opti Medical Systems, Inc. - FDA 510(k) Cleared Devices

3 submissions · 3 cleared · Since 2011
3
Total
3
Cleared
0
Denied
FDA 510(k) Regulatory Record - Opti Medical Systems, Inc. Chemistry ✕
3 devices
1-3 of 3
Cleared Aug 02, 2021
OPTI® B-Lac Cassette
K200986 · CHL
Chemistry · 474d
Cleared Aug 22, 2013
OPTI CCA-TS2
K131126 · CHL
Chemistry · 122d
Cleared Jan 07, 2011
OPTI CCA-TS, B-LAC CASSETTE MODEL BP7561
K093280 · CHL
Chemistry · 444d
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