CEDIA DAU AMPHETAMINES/ECSTASY ASSAY

Gas Chromatography, Methamphetamine

MICROGENICS CORP.

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

Pre-market Notification Details

Device IDK010496
510k NumberK010496
Device Name:CEDIA DAU AMPHETAMINES/ECSTASY ASSAY
ClassificationGas Chromatography, Methamphetamine
Applicant MICROGENICS CORP. 46360 FREMONT BLVD. Fremont,  CA  94538
ContactSherrie Rinne
CorrespondentSherrie Rinne
MICROGENICS CORP. 46360 FREMONT BLVD. Fremont,  CA  94538
Product CodeLAF  
CFR Regulation Number862.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-02-21
Decision Date2001-05-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00884883012523 K010496 000
00884883004085 K010496 000
00884883001541 K010496 000
00884883001534 K010496 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.