A-Kem, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
A-Kem, Inc. - FDA 510(k) Cleared Devices
13
Total
13
Cleared
0
Denied
A-Kem, Inc. has 13 FDA 510(k) cleared chemistry devices. Based in Clifton, US.
Historical record: 13 cleared submissions from 1987 to 1988.
Browse the complete list of FDA 510(k) cleared chemistry devices from this manufacturer. Filter by specialty or product code using the sidebar.
FDA 510(k) Regulatory Record - A-Kem, Inc.
13 devices
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