Em Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
288
Total
288
Cleared
0
Denied
259 devices
Cleared
Jan 27, 1994
ASPARTATE AMINOTRANSFERASE (AST) TEST
Chemistry
93d
Cleared
Jan 13, 1994
ALANINE AMINOTRANSFERASE (ALT) TEST
Chemistry
79d
Cleared
Dec 17, 1993
EMDS PHOSPHOROUS (PHOS) TEST
Chemistry
52d
Cleared
Dec 17, 1993
EMDS ALBUMIN (ALB) TEST
Chemistry
52d
Cleared
Dec 16, 1993
CHOLESTEROL (CHOL) TEST ITEM NO. 65410
Chemistry
49d
Cleared
Dec 16, 1993
TOTAL PROTEIN TEST (TPRO)
Chemistry
50d
Cleared
Dec 16, 1993
LACTATE DEHYDROGENASE (LD)
Chemistry
50d
Cleared
Dec 16, 1993
IRON TEST
Chemistry
50d
Cleared
Dec 16, 1993
GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST
Chemistry
51d
Cleared
Dec 09, 1993
EMDS ALKANINE PHOSPHATASE (ALP) TEST
Chemistry
43d
Cleared
Dec 09, 1993
EMDS MAGNESIUM (MG) TEST
Chemistry
43d
Cleared
Sep 27, 1993
CALCIUM TEST ITEM NUMBER 65409
Chemistry
146d
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