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. Chemistry ✕

5 devices

1-5 of 5

Cleared Aug 14, 2001

HCG STAT PAK ULTRA-FAST

Chemistry · 88d

Cleared Aug 14, 2001

SURE CHECK PREGNANCY TEST

Chemistry · 88d

Cleared May 02, 2001

SURE CHECK OVULATION PREDICTOR

Chemistry · 97d

Cleared Jun 24, 1996

SURE CHECK PREGNANCY TEST

Chemistry · 35d

Cleared Dec 24, 1992

Chemistry · 141d