AT HOME DRUG TEST, MODEL 9133 T

Enzyme Immunoassay, Phencyclidine

PHAMATECH

The following data is part of a premarket notification filed by Phamatech with the FDA for At Home Drug Test, Model 9133 T.

Pre-market Notification Details

Device IDK010651
510k NumberK010651
Device Name:AT HOME DRUG TEST, MODEL 9133 T
ClassificationEnzyme Immunoassay, Phencyclidine
Applicant PHAMATECH 9530 PADGETT ST. #101 San Diego,  CA  92126
ContactCarl A Mongiovi
CorrespondentCarl A Mongiovi
PHAMATECH 9530 PADGETT ST. #101 San Diego,  CA  92126
Product CodeLCM  
CFR Regulation Number510(k) Premarket Notification [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2001-03-05
Decision Date2001-03-30

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