Medical Device Manufacturer · US , Mchenry , IL

Mallinckrodt Critical Care - FDA 510(k) Cleared Devices

92 submissions · 92 cleared · Since 1976

Official Website

92

Total

92

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mallinckrodt Critical Care Chemistry ✕

34 devices

1-12 of 34

Cleared Jun 22, 1984

CHLORIDE TEST KIT

Chemistry · 36d

Cleared Sep 20, 1983

SODIUM TEST KIT

Chemistry · 50d

Cleared Sep 20, 1983

POTASSIUM TEST KIT

Chemistry · 50d

Cleared Jun 01, 1982

SPAC T4 RIA TEST KIT

Chemistry · 76d

Cleared Oct 06, 1981

RIA QUANT C-PEPTIDE KIT

Chemistry · 14d

Cleared Oct 06, 1981

C-PEPTIDE CONTROL PACK

Chemistry · 14d

Cleared May 15, 1981

URINE PREGNANCY TEST STANDARD/CONTR. PK

Chemistry · 18d

Cleared Feb 10, 1981

SODIUM & POTASSIUM TEST KIT

Chemistry · 11d

Cleared Jan 02, 1981

MAGNESIUM TEST KIT

Chemistry · 25d

Cleared Dec 11, 1980

CHOLESTEROL STANDARDS

Chemistry · 31d

Cleared Dec 11, 1980

COMBUNED CALCIUM AND PHOSPHORUS STD.

Chemistry · 31d

Cleared Dec 11, 1980

COMBINED GLUCOSE AND BUN STANDARDS

Chemistry · 31d