Em Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
288
Total
288
Cleared
0
Denied
259 devices
Cleared
Jul 30, 1991
ABBOTT QUICKSTART TOTAL PROTEIN TEST ITEM# 5A13
Chemistry
35d
Cleared
Jul 26, 1991
ABBOTT QUICKSTART GAMMA-GLUTAMYTRANSFERASE TEST
Chemistry
17d
Cleared
May 08, 1991
SYSTEMATE CREATININE (EPOS APPLICATION) #65413
Chemistry
141d
Cleared
Apr 12, 1991
SYSTEMATE ALKALINE PHOSPHATASE(EPOS APPL) #65483
Chemistry
58d
Cleared
Apr 12, 1991
SYSTEMATE LACTATE DEHYDROGENASE (EPOS APPL) #65476
Chemistry
58d
Cleared
Mar 11, 1991
SYSTEMATE TRIGLYCERIIDES (EPOS APPLICATION) #65477
Chemistry
26d
Cleared
Feb 13, 1991
OLYMPUS URINE PH CALIBRATORS LEVELS I AND II
Chemistry
69d
Cleared
Jan 31, 1991
SYSTEMATE TOTAL PROTEIN (EPOS APPLICATION) #65420
Chemistry
44d
Cleared
Jan 25, 1991
SYSTEMATE ALBUMIN (EPOS APPLICATION) #65401
Chemistry
38d
Cleared
Jan 15, 1991
SYSTEMATE CALCIUM (EPOS APPLICATION) #65409
Chemistry
29d
Cleared
Jan 04, 1991
SYSTEMATE GGT (EPOS APPLICATION) #65414
Chemistry
17d
Cleared
Oct 04, 1990
SYSTEMATE BICARBONATE OLYMPUS BICARBONATE
Chemistry
65d
Cleared
Sep 12, 1990
ALANINE AMINOTRANSFERASE TEST
Chemistry
55d
Cleared
Sep 12, 1990
OLYMPUS INORGANIC PHOSPHORUS
Chemistry
28d
Cleared
Sep 07, 1990
UREA NITROGEN TEST
Chemistry
44d
Cleared
Aug 17, 1990
ASPARTATE AMINOTRANSFERASE TEST
Chemistry
29d
Cleared
Aug 17, 1990
SYSTEMATE AMYLASE (AMYL) ITEM NUMBER 65404
Chemistry
23d
Cleared
Aug 17, 1990
CREATINE KINASE TEST (CK) ITEM NUMBER 65411
Chemistry
23d
Cleared
Aug 17, 1990
SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422
Chemistry
23d
Cleared
Jul 10, 1990
CREATINE KINASE-MB TEST (MB-DS) ITEM #67655
Chemistry
35d
Cleared
Jun 06, 1990
SYSTEMATE(TM) DIRECT BILIRUBIN CATALOG NO. 65406
Chemistry
26d
Cleared
May 10, 1990
OLYMPUS(TM) TOTAL BILIRUBIN
Chemistry
134d
Cleared
May 02, 1990
OLYMPUS INORGANIC PHOSPHORUS (2-REAGENT MODIFICA.)
Chemistry
12d
Cleared
Apr 16, 1990
EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95
Chemistry
40d
Cleared
Mar 29, 1990
EMDS CHOLESTEROL (CHO), ITEM NUMBERS 65410
Chemistry
35d
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