Medical Device Manufacturer · US , Medford , NY

Chembio Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices

6 submissions · 6 cleared · Since 1992

Recent clearances: HCG STAT PAK ULTRA-FAST, SURE CHECK PREGNANCY TEST, SURE CHECK OVULATION PREDICTOR

View 6 510(k) Devices ↓

6

Total

6

Cleared

0

Denied

FDA 510(k) Regulatory Record - Chembio Diagnostic Systems, Inc. Microbiology ✕

1 devices

1-1 of 1

Cleared Feb 12, 1999

PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY

Microbiology · 256d