Medical Device Manufacturer · US , Newark , DE

Dade Chemistry Systems, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1996

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - Dade Chemistry Systems, Inc. Immunology ✕

3 devices

1-3 of 3

Cleared Sep 29, 1997

PROSTATE SPECIFIC ANTIGEN CONTROL

Immunology · 41d

Cleared Sep 29, 1997

PROSTATE SPECIFIC ANTIGEN (PSA) CALIBRATOR

Immunology · 41d

Cleared Sep 18, 1997

PROSTATE SPECIFIC ANTIGEN METHOD

Immunology · 30d