DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls

Enzyme Immunoassay, Opiates

Microgenics Corporation

The following data is part of a premarket notification filed by Microgenics Corporation with the FDA for Dri Hydrocodone Assay, Dri Hydrocodone Calibrators, Dri Hydrocodone Controls.

Pre-market Notification Details

Device IDK150502
510k NumberK150502
Device Name:DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls
ClassificationEnzyme Immunoassay, Opiates
Applicant Microgenics Corporation 46500 Kato Road Fremont,  CA  94538
ContactTammy Wharton
CorrespondentLaurie Wong
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 Received2015-02-26
Decision Date2015-10-09
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883000407 K150502 000
00884883000391 K150502 000
00884883000384 K150502 000
00884883000377 K150502 000
00884883000360 K150502 000

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