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Microgenics Corporation

21 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
Alinity c Benzodiazepines Reagent Kit (K243498)Microgenics Corporation2024-12-11
DRI Ecstasy Plus Assay (K240670)Microgenics Corporation2024-10-30
Alinity c Tricyclic Antidepressants Reagent Kit (K231020)Microgenics Corporation2023-11-17
CEDIA Heroin Metabolite (6-AM) Assay (K231007)Microgenics Corporation2023-09-27
DRI TM Tricyclics Serum Tox Assay (K213875)Microgenics Corporation2022-12-21
DRI Cocaine Metabolite Assay (K211973)Microgenics Corporation2021-09-24
CEDIA Heroin Metabolite (6-AM) assay (K192943)Microgenics Corporation2019-12-16
CEDIA Benzodiazepine Assay (K190968)Microgenics Corporation2019-12-09
QMS Plazomicin Immunoassay (DEN180030)Microgenics Corporation2018-11-19
DRI Cocaine Metabolite Assay (K181499)Microgenics Corporation2018-07-06
DRI Benzodiazepine Assay (K173963)Microgenics Corporation2018-02-21
DRI Hydrocodone Assay (K173195)Microgenics Corporation2018-02-13
CEDIA Heroin Metabolite (6-AM) Assay (K173183)Microgenics Corporation2017-11-22
CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set (K163101)Microgenics Corporation2017-04-06
DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls (K150502)Microgenics Corporation2015-10-09
ABBOTT CARBAMAZEPINE ASSAY (K123518)Microgenics Corporation2013-06-05
ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS (K120936)Microgenics Corporation2012-12-13
THERMO SCIENTIFIC MAS OMNI-CARDIO (K122291)Microgenics Corporation2012-08-31
THERMO SCIENTIFIC MAS OMNI-CORE (K110738)Microgenics Corporation2011-11-03
THERMO SCIENTIFIC MAS R DOA TOTAL (K103656)Microgenics Corporation2011-03-24
MAS AND MINI-TROL PTH CONTROL (K092749)Microgenics Corporation2009-12-03

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Every clearance here is in the API, with alerts when new ones post.