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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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