CEDIA BUPRENORPHINE ASSAY

Enzyme Immunoassay, Opiates

MICROGENICS CORP.

The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Buprenorphine Assay.

Pre-market Notification Details

Device IDK040316
510k NumberK040316
Device Name:CEDIA BUPRENORPHINE ASSAY
ClassificationEnzyme Immunoassay, Opiates
Applicant MICROGENICS CORP. 46360 FREMONT BLVD. Fremont,  CA  94538
ContactDavid Casal
CorrespondentDavid Casal
MICROGENICS CORP. 46360 FREMONT BLVD. 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 Received2004-02-09
Decision Date2004-06-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883011670 K040316 000
00884883001756 K040316 000
00884883001749 K040316 000
00884883001732 K040316 000
00884883001725 K040316 000
00884883001718 K040316 000
00884883001701 K040316 000
00884883001695 K040316 000
00884883001602 K040316 000

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