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Em Diagnostic Systems, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
288
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K935181ASPARTATE AMINOTRANSFERASE (AST) TESTJanuary 27, 1994
K935180ALANINE AMINOTRANSFERASE (ALT) TESTJanuary 13, 1994
K935178EMDS PHOSPHOROUS (PHOS) TESTDecember 17, 1993
K935179EMDS ALBUMIN (ALB) TESTDecember 17, 1993
K935175LACTATE DEHYDROGENASE (LD)December 16, 1993
K935174TOTAL PROTEIN TEST (TPRO)December 16, 1993
K935176IRON TESTDecember 16, 1993
K935177GAMMA-GLUTAMYL TRANSFERASE (GGT) TESTDecember 16, 1993
K935136CHOLESTEROL (CHOL) TEST ITEM NO. 65410December 16, 1993
K935182EMDS ALKANINE PHOSPHATASE (ALP) TESTDecember 9, 1993
K935183EMDS MAGNESIUM (MG) TESTDecember 9, 1993
K932158CALCIUM TEST ITEM NUMBER 65409September 27, 1993
K932162URIC ACID TEST ITEM NUMBER 65422September 27, 1993
K932159SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406September 21, 1993
K932161UREA NITROGEN TEST ITEM NUMBER 65408September 8, 1993
K931891TRIGLYCERIDESAugust 25, 1993
K931582ETHYLIDENE AMYLAugust 19, 1993
K931583SILYL AMYLAugust 19, 1993
K931887BICARBONATEAugust 3, 1993
K931889CREATINE KINASE TESTJuly 27, 1993