CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set

Enzyme Immunoassay, Opiates

MICROGENICS CORPORATION

The following data is part of a premarket notification filed by Microgenics Corporation with the FDA for Cedia Buprenorphine Ii Assay; Cedia Buprenorphine Ii Calibrators; Cedia Negative Calibrator Ii; Cedia Buprenorphine Ii Control Set.

Pre-market Notification Details

Device IDK163101
510k NumberK163101
Device Name:CEDIA Buprenorphine II Assay; CEDIA Buprenorphine II Calibrators; CEDIA Negative Calibrator II; CEDIA Buprenorphine II Control Set
ClassificationEnzyme Immunoassay, Opiates
Applicant MICROGENICS CORPORATION 46500 KATO ROAD Fremont,  CA  94538
ContactMinoti Patel
CorrespondentMinoti Patel
MICROGENICS CORPORATION 46500 KATO ROAD Fremont,  CA  94538
Product CodeDJG  
Subsequent Product CodeDLJ
Subsequent Product CodeLAS
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2016-11-07
Decision Date2017-04-06
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883006065 K163101 000
00884883006058 K163101 000
00884883006041 K163101 000
00884883006034 K163101 000
00884883004832 K163101 000
00884883004757 K163101 000
00884883003873 K163101 000
00884883003491 K163101 000

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