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. Chemistry ✕

10 devices

1-10 of 10

Cleared Oct 20, 1997

TROPONIN (TROP) METHOD

Chemistry · 25d

Cleared Apr 28, 1997

FT4 METHOD FOR THE DIMENSION RXL CLINICAL CHEMISTRY SYSTEM

Chemistry · 31d

Cleared Mar 10, 1997

HUMAN CHORIONIC GONADOTROPIN METHOD

Chemistry · 35d

Cleared Mar 03, 1997

Chemistry · 33d

Cleared Mar 03, 1997

THYROID STIMULATING HORMONE METHOD

Chemistry · 28d

Cleared Feb 20, 1997

HUMAN CHORIONIC GONADOTROPIN CALIBRATOR

Chemistry · 17d

Cleared Feb 18, 1997

THYROID CALIBRATOR

Chemistry · 15d

Cleared Feb 14, 1997

Chemistry · 16d

Cleared Jan 24, 1997

FERR FLEX REAGENT CARTRIDGE

Chemistry · 143d

Cleared Dec 03, 1996

FERRITIN CALIBRATOR

Chemistry · 91d