Em Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
288
Total
288
Cleared
0
Denied
259 devices
Cleared
Jul 27, 1987
EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95
Chemistry
40d
Cleared
Jul 01, 1987
EASY-TEST AMMONIA (AMON) ITEM NO. 16695
Chemistry
30d
Cleared
May 12, 1987
EASY-TEST CHEM CAL LEVELS 1,2&3/ITEMS 67617 ABC/95
Chemistry
15d
Cleared
Apr 23, 1987
EMDS TIBC PRETREATMENT SET ITEM NO. 67612/93
Chemistry
15d
Cleared
Mar 19, 1987
EASY-TEST URIC ACID (URIC) #16606
Chemistry
16d
Cleared
Mar 10, 1987
EASY-TEST CREATINE KINASE-MB (CK-MB) #16615
Chemistry
35d
Cleared
Mar 06, 1987
EASY-TEST CALCIUM (CA), ITEM NO. 67528/93
Chemistry
51d
Cleared
Mar 06, 1987
EASY-TEST CREATINE KINASE (CK) NUMBER: 16614
Chemistry
31d
Cleared
Mar 06, 1987
EASY-TEST MAGNESIUM (MG) ITEM NO. 16XXX
Chemistry
24d
Cleared
Mar 04, 1987
EASY-TEST CHOLESTEROL(CHOL) NUMBER 16607
Chemistry
29d
Cleared
Mar 04, 1987
EASY-TEST TRIGLYCERIDE (TRIG) NUMBER 16608
Chemistry
29d
Cleared
Mar 04, 1987
EMDS UREA NITROGEN (BUN) TESTPACKS ITEM #67654/95
Chemistry
22d
Cleared
Feb 20, 1987
IRON(IRN) TESTPACK, ITEM NO. 67659/95
Chemistry
38d
Cleared
Feb 11, 1987
AMMONIA (AMON) TESTPACK, ITEM NO. 67689/95
Chemistry
29d
Cleared
Feb 11, 1987
EMIT QUINIDINE CALIBRATOR ITEM NO. 67631/93
Chemistry
21d
Cleared
Dec 31, 1986
EASY-TEST ALBUMIN (ALB), ITEM NO. 67529/93
Chemistry
28d
Cleared
Nov 28, 1986
EMDS(TM) ALANINE AMINOTRANSFERASE (ALT) #67658/95
Chemistry
49d
Cleared
Nov 28, 1986
EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95
Chemistry
49d
Cleared
Nov 05, 1986
EMDS(TM) CREATININE(CREA) TESTPACKS, #67669/95
Chemistry
43d
Cleared
Oct 29, 1986
CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95
Chemistry
50d
Cleared
Oct 29, 1986
EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95
Chemistry
41d
Cleared
Oct 29, 1986
EMDS(TM) PHOSPHORUS (PHOS) TESTPACKS, #67678/95
Chemistry
36d
Cleared
Sep 29, 1986
EASY-TEST CARBON DIOXIDE (CO2) ITEM #67649/95
Chemistry
17d
Cleared
Sep 26, 1986
EMDS(TM) LACTIC DEHYDROGENASE TESTPACKS, #67660/95
Chemistry
17d
Cleared
Sep 25, 1986
EASY-TEST LACTIC DEHYDROGENASE (LDH) # 67527/95
Chemistry
13d
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