Medical Device Manufacturer · US , Cortlandt Manor , NY

Polymedco, Inc. - FDA 510(k) Cleared Devices

19 submissions · 19 cleared · Since 1992

19

Total

19

Cleared

0

Denied

FDA 510(k) Regulatory Record - Polymedco, Inc. Immunology ✕

4 devices

1-4 of 4

Cleared Aug 20, 2001

POLYTITER SYSTEM

Immunology · 40d

Cleared Dec 18, 1996

C-REACTIVE PROTEIN (CRP) AGGLUTINATION LATEX KIT

Immunology · 204d

Cleared Dec 20, 1995

TEST, RHEUMATOID FACTOR

Immunology · 43d

Cleared Feb 23, 1993

CANCER ANTIGEN CONTROL

Immunology · 195d