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Em Diagnostic Systems, Inc.

FDA 510(k) & PMA Approved Devices — 288 products

Total Devices288
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K935181 ASPARTATE AMINOTRANSFERASE (AST) TESTCIT1994-01-27 View
510(k) K935180 ALANINE AMINOTRANSFERASE (ALT) TESTCKA1994-01-13 View
510(k) K935178 EMDS PHOSPHOROUS (PHOS) TESTCEO1993-12-17 View
510(k) K935179 EMDS ALBUMIN (ALB) TESTCIX1993-12-17 View
510(k) K935176 IRON TESTJIY1993-12-16 View
510(k) K935177 GAMMA-GLUTAMYL TRANSFERASE (GGT) TESTJQB1993-12-16 View
510(k) K935175 LACTATE DEHYDROGENASE (LD)CFJ1993-12-16 View
510(k) K935136 CHOLESTEROL (CHOL) TEST ITEM NO. 65410CHH1993-12-16 View
510(k) K935174 TOTAL PROTEIN TEST (TPRO)CEK1993-12-16 View
510(k) K935183 EMDS MAGNESIUM (MG) TESTJGJ1993-12-09 View
510(k) K935182 EMDS ALKANINE PHOSPHATASE (ALP) TESTCJE1993-12-09 View
510(k) K932158 CALCIUM TEST ITEM NUMBER 65409CIC1993-09-27 View
510(k) K932162 URIC ACID TEST ITEM NUMBER 65422CDO1993-09-27 View
510(k) K932159 SYSTEMATE DIRECT BILIRUBIN CAT. NO. 65406CIG1993-09-21 View
510(k) K932161 UREA NITROGEN TEST ITEM NUMBER 65408CDQ1993-09-08 View
510(k) K931891 TRIGLYCERIDESCDT1993-08-25 View
510(k) K931583 SILYL AMYLJFJ1993-08-19 View
510(k) K931582 ETHYLIDENE AMYLJFJ1993-08-19 View
510(k) K931887 BICARBONATEKHS1993-08-03 View
510(k) K931888 TOTAL BILIRUBINCIG1993-07-27 View
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