FDA 510(k) Applications Submitted by MICROGENICS CORPORATION

FDA 510(k) Number Submission Date Device Name Applicant
K231007 04/07/2023 CEDIA Heroin Metabolite (6-AM) Assay Microgenics Corporation
K181499 06/07/2018 DRI Cocaine Metabolite Assay Microgenics Corporation
K120936 03/28/2012 ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS Microgenics Corporation
K122291 07/31/2012 THERMO SCIENTIFIC MAS OMNI-CARDIO Microgenics Corporation
K123518 11/14/2012 ABBOTT CARBAMAZEPINE ASSAY Microgenics Corporation
K110738 03/17/2011 THERMO SCIENTIFIC MAS OMNI-CORE Microgenics Corporation
K092749 09/08/2009 MAS AND MINI-TROL PTH CONTROL Microgenics Corporation
K103656 12/15/2010 THERMO SCIENTIFIC MAS R DOA TOTAL Microgenics Corporation
K190968 04/12/2019 CEDIA Benzodiazepine Assay Microgenics Corporation
DEN180030 06/25/2018 QMS Plazomicin Immunoassay Microgenics Corporation
K173183 10/02/2017 CEDIA Heroin Metabolite (6-AM) Assay Microgenics Corporation
K173195 10/02/2017 DRI Hydrocodone Assay Microgenics Corporation
K163101 11/07/2016 CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set MICROGENICS CORPORATION
K173963 12/28/2017 DRI Benzodiazepine Assay Microgenics Corporation
K211973 06/25/2021 DRI Cocaine Metabolite Assay Microgenics Corporation
K213875 12/13/2021 DRI TM Tricyclics Serum Tox Assay Microgenics Corporation
K192943 10/18/2019 CEDIA Heroin Metabolite (6-AM) assay Microgenics Corporation
K150502 02/26/2015 DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls Microgenics Corporation


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