AT HOME DRUG TEST, MODEL 9068

Gas Chromatography, Methamphetamine

PHAMATECH

The following data is part of a premarket notification filed by Phamatech with the FDA for At Home Drug Test, Model 9068.

Pre-market Notification Details

Device IDK994233
510k NumberK994233
Device Name:AT HOME DRUG TEST, MODEL 9068
ClassificationGas Chromatography, Methamphetamine
Applicant PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego,  CA  92126
ContactCarl A Mongiovi
CorrespondentCarl A Mongiovi
PHAMATECH 9265 ACTIVITY RD., #112-113 San Diego,  CA  92126
Product CodeLAF  
CFR Regulation Number862.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-12-16
Decision Date1999-12-30
Summary:summary

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