Advanced Biomedical Methods, Inc. - FDA 510(k) Cleared Devices
21
Total
21
Cleared
0
Denied
FDA 510(k) Regulatory Record - Advanced Biomedical Methods, Inc. Chemistry ✕
20 devices
Cleared
Dec 09, 1994
CLARIT(TM)
Chemistry
50d
Cleared
Apr 05, 1988
SINGLE REAGENT CALCIUM FOR DEMAND ANALYZER
Chemistry
29d
Cleared
Mar 16, 1987
RESUBMISSION OF THE KLEERZIT REAGENT
Chemistry
95d
Cleared
Jul 22, 1985
SGOT/ALT REAGENT
Chemistry
21d
Cleared
Jul 22, 1985
ALKALINE PHOSPHATASE
Chemistry
21d
Cleared
Mar 01, 1985
LDH REAGENT FOR DEMAND ANALYZER
Chemistry
29d
Cleared
Mar 01, 1985
DIRECT BILIRUBIN FOR DEMAND ANALYZER
Chemistry
29d
Cleared
Mar 01, 1985
INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER
Chemistry
29d
Cleared
Mar 01, 1985
MAGNESIUM REAGENT FOR DEMAND ANALYZER
Chemistry
29d
Cleared
Jan 03, 1985
CALCIUM REAGENT FOR DEMAND ANALYZER
Chemistry
63d
Cleared
Jan 03, 1985
CHOLESTEROL REAGENT FOR DEMAND ANALYZER
Chemistry
63d
Cleared
Jan 03, 1985
TOTAL BILIRUBIN FOR DEMAND ANALYZER
Chemistry
63d
Cleared
Jan 03, 1985
ALBUMIN REAGENT FOR DEMAND ANALYZER
Chemistry
57d
Cleared
Jan 03, 1985
TOTAL PROTEIN REAGENT FOR DEMAND ANALYZER
Chemistry
57d
Cleared
Jan 03, 1985
CREATININE REAGENT FOR DEMAND ANALYZER
Chemistry
57d
Cleared
Dec 10, 1984
ISE REAGENTS FOR DEMAND ANALYZER
Chemistry
56d
Cleared
Sep 15, 1977
CHOLOPAP-HDL
Chemistry
28d
Cleared
Dec 09, 1976
S-UREA-N, IN VITRO DIAG FOR BUN
Chemistry
10d
Cleared
Dec 09, 1976
GLUC OPAP, IN VITRO DIAG. FOR GLUCOSE
Chemistry
10d
Cleared
Dec 09, 1976
GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZ
Chemistry
10d