Em Diagnostic Systems, Inc. - FDA 510(k) Cleared Devices
288
Total
288
Cleared
0
Denied
288 devices
Cleared
Sep 16, 1986
EMDS(TM) CALCIUM TESTPACKS, #67687/95
Chemistry
39d
Cleared
Sep 16, 1986
EMDS(TM) ALBUMIN TESTPACKS, #67652/95
Chemistry
39d
Cleared
Aug 29, 1986
EMDS (TM) HDL CHOLESTEROL ITEM NO. 67679/95
Chemistry
31d
Cleared
Aug 29, 1986
EMDS(TM) TOTAL PROTEIN TESTPACKS, #67663/95
Chemistry
21d
Cleared
Aug 29, 1986
SYSTEMATE (TM) ALANINE TRANSFERASE (ALT)
Chemistry
16d
Cleared
Aug 19, 1986
EMDS THEOPHYLLINE CALIBRATORS ITEM NO. 67---/93
Chemistry
53d
Cleared
Aug 19, 1986
EMDS(TM) DICHROME QC TEST SOLUTION ITEM # 67447/95
Chemistry
48d
Cleared
Aug 19, 1986
EMDS(TM) ELEVATED BILIRUBIN CALIBRATOR # 67627/95
Chemistry
35d
Cleared
Aug 19, 1986
EMDS(TM) TRIGLYCERIDE TESTPACKS #67674/95
Chemistry
34d
Cleared
Aug 19, 1986
EMDS(TM) CHOLESTEROL TESTPACK, # 67685/95
Chemistry
34d
Cleared
Aug 19, 1986
EMDS(TM) MAGNESIUM TESTPACKS, #67671/95
Chemistry
11d
Cleared
Aug 04, 1986
EMDS(TM) ELEVATED LIPID CALIBRATOR #67626/95
Chemistry
20d
Cleared
Jul 07, 1986
EASY-TEST (TM) EMIT* PHENOBARBITAL (PHNO)/67534/93
Toxicology
20d
Cleared
Jul 07, 1986
EASY-TEST EMIT PHENYTOIN(PHTN) ITEM # 67535/93
Toxicology
17d
Cleared
Jul 07, 1986
EASY-TEST EMIT* THEOPHYLLINE(THEO) ITEM 67533/93
Toxicology
17d
Cleared
May 23, 1986
EMDS AMYLASE (AMYL) TEST PACKS, # 67653/95
Chemistry
72d
Cleared
May 23, 1986
EMDS, CK/CK-MB VERIFIER, ITEM NUMBER 67---/95
Chemistry
30d
Cleared
Apr 24, 1986
EASY-TEST ISE CALIBRATOR, ITEM NO. 67566/95
Chemistry
36d
Cleared
Apr 24, 1986
EMDS CREATINE KINASE ISOENZYME CKMB TEST PACK
Chemistry
35d
Cleared
Apr 24, 1986
EASY-TEST CHEK (INSTRUM. CHECK) & EMDS ABS TEST
Chemistry
23d
Cleared
Apr 09, 1986
EASY-TEST (GGT) REAGENT, ITEM NO. 67526/93
Chemistry
48d
Cleared
Apr 07, 1986
ION-SPECIFIC ELECTRODE, CHLORIDE
Chemistry
42d
Cleared
Apr 07, 1986
CREATINE KINASE, N-ACETYL-L-CYSTIENE
Chemistry
42d
Cleared
Apr 07, 1986
EMDS ENZYME VERIFIER, LEVELS I & II
Chemistry
35d
Cleared
Apr 07, 1986
EMDS CHEMISTRY CALIBRATORS, LEVELS I & II
Chemistry
35d
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