Em Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
288
Total
288
Cleared
0
Denied
259 devices
Cleared
Jan 15, 1992
ABBOTT QUICKSTART TIGLYCERIDES REAGENT
Chemistry
26d
Cleared
Jan 03, 1992
ABBOTT QUICKSTART SGOT, ITEM NUMBER: 5A42
Chemistry
88d
Cleared
Dec 31, 1991
QUICKSTART UREA NITROGEN
Chemistry
60d
Cleared
Dec 18, 1991
ABBOTT QUICKSTART CHOLESTEROL TEST
Chemistry
131d
Cleared
Dec 13, 1991
CREATINE KINASE MB TEST ITEM NUMBER 5A46
Chemistry
73d
Cleared
Nov 22, 1991
ABBOTT QUICKSTART ALKA PHOSPHATASE (ALP) ITEM#5A38
Chemistry
80d
Cleared
Nov 22, 1991
ABBOTT QUICKSTART TRIGLYCERIDES REAGENTS, #5A33
Chemistry
74d
Cleared
Nov 22, 1991
ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43
Chemistry
46d
Cleared
Nov 05, 1991
ABBOTT QUICKSTART MAGNESIUM TEST, ITEM #5A32
Chemistry
75d
Cleared
Oct 31, 1991
ABBOTT QUICK START CREATINE KINASE(CK) ITEM #5A17
Chemistry
128d
Cleared
Oct 25, 1991
ABBOTT QUICKSTART DIRECT BILIRUBIN (DBIL) #5A20
Chemistry
81d
Cleared
Oct 21, 1991
ABBOTT QUICKSTART LD-1,#5A30
Chemistry
28d
Cleared
Oct 11, 1991
ABBOTT QUICKSTART TOTAL BILIRUBIN (TBIL) #5A21
Chemistry
78d
Cleared
Oct 11, 1991
ABBOTT QUICKSTART LDH,#5A31
Chemistry
18d
Cleared
Oct 09, 1991
ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16
Chemistry
92d
Cleared
Oct 09, 1991
ABBOTT QLUICKSTART IRON TEST, ITEM #5A29
Chemistry
51d
Cleared
Oct 02, 1991
ABBOTT QUICKSTART ASPARATE AMINOTRANSFERASE TEST
Chemistry
21d
Cleared
Sep 27, 1991
ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34
Chemistry
39d
Cleared
Sep 27, 1991
ABBOTT QUICKSTART ALBUMIN TEST (ALBG) ITEM #5A37
Chemistry
24d
Cleared
Sep 19, 1991
ABBOTT QUICKSTART ALANINE AMINOTRANSFER
Chemistry
22d
Cleared
Sep 19, 1991
ABBOTT QUICKSTART TIBC PRETREATMENT KIT, 5A29-01
Chemistry
16d
Cleared
Sep 18, 1991
ABBOTT QUICKSTART CREATININE TEST(CREA) ITEM# 5A28
Chemistry
30d
Cleared
Sep 11, 1991
ABBOTT QUICKSTART BICARBONATE TEST CO2 ITEM# 5A22
Chemistry
78d
Cleared
Aug 12, 1991
ABBOTT QUICKSTART PHOSPHORUS(PHOS) ITEM #5A14
Chemistry
48d
Cleared
Jul 30, 1991
ABBOTT QUICK START GLUCOSE (GLUE) ITEM# 5A15
Chemistry
35d
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