DRI ECSTASY URINE CALIBRATORS

Calibrators, Drug Specific

MICROGENICS CORP.

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

Pre-market Notification Details

Device IDK012109
510k NumberK012109
Device Name:DRI ECSTASY URINE CALIBRATORS
ClassificationCalibrators, Drug Specific
Applicant MICROGENICS CORP. 46360 FREMONT BLVD. Fremont,  CA  94538
ContactSherrie Rinne
CorrespondentSherrie Rinne
MICROGENICS CORP. 46360 FREMONT BLVD. Fremont,  CA  94538
Product CodeDLJ  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-07-06
Decision Date2001-08-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740005757 K012109 000
00380740005726 K012109 000
00380740005719 K012109 000
00380740005702 K012109 000
00380740005696 K012109 000
00884883001404 K012109 000
00884883001398 K012109 000
00884883001381 K012109 000
00884883001374 K012109 000

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