DRI ECSTASY ENZYME IMMUNOASSAY

Enzyme Immunoassay, Amphetamine

MICROGENICS CORP.

The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Dri Ecstasy Enzyme Immunoassay.

Pre-market Notification Details

Device IDK012110
510k NumberK012110
Device Name:DRI ECSTASY ENZYME IMMUNOASSAY
ClassificationEnzyme Immunoassay, Amphetamine
Applicant MICROGENICS CORP. 46360 FREMONT BLVD. Fremont,  CA  94538
ContactSherrie Rinne
CorrespondentSherrie Rinne
MICROGENICS CORP. 46360 FREMONT BLVD. Fremont,  CA  94538
Product CodeDKZ  
CFR Regulation Number862.3100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-06
Decision Date2001-08-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883011342 K012110 000
00884883006751 K012110 000
00884883002883 K012110 000
00884883001350 K012110 000
00380740165222 K012110 000
00380740005757 K012110 000

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