Medical Device Manufacturer · US , Clifton , NJ

A-Kem, Inc. - FDA 510(k) Cleared Devices

13 submissions · 13 cleared · Since 1987

13

Total

13

Cleared

0

Denied

FDA 510(k) Regulatory Record - A-Kem, Inc. Chemistry ✕

13 devices

1-13 of 13

Cleared Dec 15, 1988

TOTAL BILIRUBIN REAGENT KIT FOR ASTRA SYSTEMS

Chemistry · 70d

Cleared Dec 09, 1988

TOTAL PROTEIN REAGENT KIT FOR ASTRA SYSTEMS

Chemistry · 64d

Cleared Dec 09, 1988

AMYLASE REAGENT KIT FOR ASTRA SYSTEMS

Chemistry · 64d

Cleared Dec 09, 1988

CALIBRATOR STANDARD KIT FOR ASTRA SYSTEM

Chemistry · 64d

Cleared Aug 08, 1988

A-KEM CALCIUM REAGENT KIT FOR ASTRA SYSTEM

Chemistry · 46d

Cleared Aug 08, 1988

A-KEM ALBUMIN REAGENT KIT FOR ASTRA SYSTEM

Chemistry · 46d

Cleared Oct 23, 1987

SODIUM/POTASSIUM REAGENT KIT

Chemistry · 74d

Cleared Oct 23, 1987

CHLORIDE REAGENT KIT

Chemistry · 74d

Cleared Oct 23, 1987

GLUCOSE REAGENT KIT

Chemistry · 74d

Cleared Oct 23, 1987

CARBON DIOXIDE REAGENT KIT

Chemistry · 74d

Cleared Oct 23, 1987

WASH SOLUTION KIT

Chemistry · 74d

Cleared Oct 23, 1987

CREATININE REAGENT KIT

Chemistry · 74d

Cleared Oct 23, 1987

BUN REAGENT KIT

Chemistry · 74d