FDA 510(k) Applications Submitted by Minoti Patel

FDA 510(k) Number Submission Date Device Name Applicant
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


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