Em Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
288
Total
288
Cleared
0
Denied
259 devices
Cleared
Mar 31, 1989
REVISED MAGNESIUM TEST ITEM NUMBER: SR1019
Chemistry
42d
Cleared
Feb 17, 1989
CHOLESTEROL TEST ITEM NUMBER: SR1011
Chemistry
74d
Cleared
Feb 17, 1989
BICARBONATE TEST ITEM NUMBER: SR1006
Chemistry
25d
Cleared
Feb 10, 1989
CREATINE KINASE-MB TEST (CK-MK) ITEM NUMBER 65673
Chemistry
102d
Cleared
Feb 10, 1989
HDL CHOLESTEROL TEST
Chemistry
50d
Cleared
Feb 10, 1989
IRON REAGENTS ITEM NUMBER: SR1017
Chemistry
18d
Cleared
Feb 07, 1989
OLYMPUS TRIGLYCERIDES REAGENTS #SR1021
Chemistry
47d
Cleared
Feb 02, 1989
CREATINE KINASE TEST (CK) ITEM NUMBER: 65661
Chemistry
94d
Cleared
Jan 30, 1989
TOTAL BILIRUBIN TEST CATALOG NO. SR1007
Chemistry
38d
Cleared
Jan 30, 1989
DIRECT BILIRUBIN TEST CATALOG NO. SR1008
Chemistry
38d
Cleared
Jan 23, 1989
TOTAL PROTEIN TEST (TP) ITEM #65670
Chemistry
75d
Cleared
Jan 23, 1989
URIC ACID TEST (URIC) ITEM #65620
Chemistry
75d
Cleared
Jan 17, 1989
MAGNESIUM TEST ITEM NUMBER: SR1019
Chemistry
43d
Cleared
Jan 13, 1989
CALCIUM TEST ITEM NUMBER: SR1009
Chemistry
43d
Cleared
Jan 13, 1989
UREA NITROGEN TEST (BUN) ITEM NUMBER: SR1022
Chemistry
43d
Cleared
Jan 13, 1989
GAMMA GLUTAMYL TRANSFERASE TEST (GGT) ITEM: 65664
Chemistry
43d
Cleared
Jan 11, 1989
ALANINE AMINOTRANSFERASE TEST ITEM NO. 65652
Chemistry
85d
Cleared
Jan 11, 1989
AMYLASE TEST (AMYL) ITEM NUMBER: 65653
Chemistry
85d
Cleared
Jan 11, 1989
ALBUMIN TEST (ALB) ITEM #65650
Chemistry
63d
Cleared
Jan 11, 1989
CHLORIDE TEST (CL) ITEM #65659
Chemistry
63d
Cleared
Jan 03, 1989
GLUCOSE-HK TEST (GLUC-HK) ITEM #65665
Chemistry
50d
Cleared
Dec 19, 1988
CREATININE TEST (CREA) ITEM #65663
Chemistry
35d
Cleared
Dec 16, 1988
PHOSPHORUS TEST (PHOS) ITEM #65666
Chemistry
32d
Cleared
Dec 14, 1988
ASPARTATE AMINOTRANSFERASE TEST ITEM NO. 65654
Chemistry
57d
Cleared
Nov 10, 1988
EMDS GLUCOSE (GLUC) TESTPACKS, NO. 67697/95
Chemistry
49d
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