Medical Device Manufacturer · US , Medford , NY

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

6 submissions · 6 cleared · Since 1992

6

Total

6

Cleared

0

Denied

Chembio Diagnostic Systems, Inc. has 6 FDA 510(k) cleared medical devices. Based in Medford, US.

Historical record: 6 cleared submissions from 1992 to 2001. Primary specialty: Chemistry.

Browse the FDA 510(k) cleared devices submitted by Chembio Diagnostic Systems, Inc. Filter by specialty or product code using the sidebar.

6 devices

1–6 of 6

HCG STAT PAK ULTRA-FAST

K011550 · JHI Visual, Pregnancy Hcg, Prescription Use · Chemistry

SURE CHECK PREGNANCY TEST

K011551 · LCX Kit, Test, Pregnancy, Hcg, Over The Counter · Chemistry

SURE CHECK OVULATION PREDICTOR

K010244 · CEP Radioimmunoassay, Luteinizing Hormone · Chemistry

PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAY

K981913 · LSR Reagent, Borrelia Serological Reagent · Microbiology

SURE CHECK PREGNANCY TEST

K961965 · LCX Kit, Test, Pregnancy, Hcg, Over The Counter · Chemistry

K923925 · JHI Visual, Pregnancy Hcg, Prescription Use · Chemistry