Em Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
288
Total
288
Cleared
0
Denied
288 devices
Cleared
Oct 29, 1987
EMDS AMIKACIN CALIBRATOR ITEM NO. 67633/95
Chemistry
63d
Cleared
Oct 29, 1987
EASY-TEST ALKALINE PHOSPHATASE (ALP) #19021
Chemistry
50d
Cleared
Oct 29, 1987
EASY-TEST ALBUMIN (ALB), ITEM NO. 19039
Chemistry
28d
Cleared
Oct 02, 1987
CONJUGATED BILIRUBIN (CBIL) ITEM NO. 67684/95
Chemistry
32d
Cleared
Sep 29, 1987
EASY-TEST EMIT PROCAINAMIDE (PROC) #16648
Toxicology
40d
Cleared
Sep 29, 1987
ALKALINE PHOSPHATASE (ALK P) TESTPACK #67690/95
Chemistry
15d
Cleared
Sep 22, 1987
EASY-TEST EMIT N-ACETYLPROCAINAMIDE NAPA #16649
Toxicology
33d
Cleared
Sep 14, 1987
EASY-TEST CONJUGATED BILIRUBIN (CBIL) #16690
Chemistry
20d
Cleared
Aug 28, 1987
EMDS SALICYLATE (SAL) CALIBRATOR, NO# 67641/93
Chemistry
72d
Cleared
Aug 21, 1987
EMDS TOTAL BILIRUBIN (TBIL) TESTPACKS, #67675/95
Chemistry
58d
Cleared
Aug 21, 1987
EASY-TEST TOTAL BILIRUBIN (TBIL) ITEM NO. 16604
Chemistry
58d
Cleared
Aug 13, 1987
EASY ST ANALYZER SYSTEM
Chemistry
28d
Cleared
Jul 27, 1987
EASY-TEST GAMMA-GLUTAMYL TRANSFERASE (GGT) 16616
Chemistry
40d
Cleared
Jul 27, 1987
EMDS GAMMA-GLUTAMYL TRANSFERASE (GGT) 67680/95
Chemistry
40d
Cleared
Jul 23, 1987
EASY-TEST HEMOGLOBIN (HGB) ITEM #16685
Hematology
16d
Cleared
Jul 09, 1987
EMDS SALICYLATE (SAL) TESTPACKS, ITEM NO. 67694/95
Toxicology
22d
Cleared
Jul 01, 1987
EASY-TEST AMMONIA (AMON) ITEM NO. 16695
Chemistry
30d
Cleared
May 12, 1987
EASY-TEST EMIT GENTAMICIN (GENT) ITEM NO. 16640
Toxicology
39d
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
Apr 22, 1987
EMDS GENTAMICIN CALIBRATOR ITEM NO. 67628/95
Toxicology
19d
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
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