Diagnostic Systems - FDA 510(k) Cleared Devices
14
Total
14
Cleared
0
Denied
FDA 510(k) Regulatory Record - Diagnostic Systems Chemistry ✕
12 devices
Cleared
Feb 04, 1991
OLYMPUS URINE PH
Chemistry
81d
Cleared
Aug 31, 1989
EMDS CREATINE KINASE ITEM NIMBER 65411
Chemistry
107d
Cleared
Aug 21, 1989
EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405
Chemistry
97d
Cleared
Jul 25, 1989
HDL PRECIPITATING REAGENT
Chemistry
53d
Cleared
Dec 29, 1988
VISUAL BLOOD GLUCOSE TEST SYSTEM
Chemistry
28d
Cleared
Mar 15, 1988
EASY-TEST LACTIC ACID (LA)
Chemistry
18d
Cleared
Dec 19, 1985
ABSORBANCE (ABS) TEST PAK
Chemistry
20d
Cleared
Sep 25, 1985
EASY ANALYZER & EASY-TEST REAGENT
Chemistry
21d
Cleared
Sep 16, 1985
ALCOHOL CALIBRATORS
Chemistry
24d
Cleared
Sep 16, 1985
ABSORBANCE TEST SOLUTION
Chemistry
24d
Cleared
Apr 12, 1983
DSL 1900
Chemistry
28d
Cleared
Apr 06, 1983
MMH PTH RIA KIT
Chemistry
30d