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Diagnostic Systems

FDA 510(k) & PMA Approved Devices — 14 products

Total Devices14
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K905146 OLYMPUS URINE PHJQY1991-02-04 View
510(k) K893691 EMDS CREATINE KINASE ITEM NIMBER 65411CGS1989-08-31 View
510(k) K893692 EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405CIT1989-08-21 View
510(k) K893966 HDL PRECIPITATING REAGENTLBR1989-07-25 View
510(k) K884993 VISUAL BLOOD GLUCOSE TEST SYSTEMCGA1988-12-29 View
510(k) K881116 EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641KLR1988-06-20 View
510(k) K880787 EASY-TEST LACTIC ACID (LA)KHP1988-03-15 View
510(k) K862403 EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95DKB1986-07-11 View
510(k) K854784 ABSORBANCE (ABS) TEST PAKJIT1985-12-19 View
510(k) K853699 EASY ANALYZER & EASY-TEST REAGENTJJE1985-09-25 View
510(k) K853532 ALCOHOL CALIBRATORSDNN1985-09-16 View
510(k) K853533 ABSORBANCE TEST SOLUTIONJIT1985-09-16 View
510(k) K830816 DSL 1900CGI1983-04-12 View
510(k) K830700 MMH PTH RIA KITCEW1983-04-06 View
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