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Microgenics Corporation

FDA 510(k) & PMA Approved Devices — 13 products

Total Devices13
Categories5
Latest FDA decision2024-12-11
TypeNumberDevice NameCodeDateActions
510(k) K243498 Alinity c Benzodiazepines Reagent KitJXM2024-12-11 View
510(k) K240670 DRI Ecstasy Plus AssayDKZ2024-10-30 View
510(k) K231020 Alinity c Tricyclic Antidepressants Reagent KitLFH2023-11-17 View
510(k) K231007 CEDIA Heroin Metabolite (6-AM) AssayDJG2023-09-27 View
510(k) K213875 DRI TM Tricyclics Serum Tox AssayLFH2022-12-21 View
510(k) K211973 DRI Cocaine Metabolite AssayDIO2021-09-24 View
510(k) K192943 CEDIA Heroin Metabolite (6-AM) assayDJG2019-12-16 View
510(k) K190968 CEDIA Benzodiazepine AssayJXM2019-12-09 View
510(k) K181499 DRI Cocaine Metabolite AssayDIO2018-07-06 View
510(k) K173963 DRI Benzodiazepine AssayJXM2018-02-21 View
510(k) K173195 DRI Hydrocodone AssayDJG2018-02-13 View
510(k) K173183 CEDIA Heroin Metabolite (6-AM) AssayDJG2017-11-22 View
510(k) K163101 CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control SetDJG2017-04-06 View
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