Psychemedics Homogeneous Enzyme Immunoassay For Amphetamines In Hair

Gas Chromatography, Methamphetamine

Psychemedics Corporation

The following data is part of a premarket notification filed by Psychemedics Corporation with the FDA for Psychemedics Homogeneous Enzyme Immunoassay For Amphetamines In Hair.

Pre-market Notification Details

Device IDK210212
510k NumberK210212
Device Name:Psychemedics Homogeneous Enzyme Immunoassay For Amphetamines In Hair
ClassificationGas Chromatography, Methamphetamine
Applicant Psychemedics Corporation 5832 Uplander Way Culver City,  CA  90230
ContactNeil Stowe
CorrespondentNeil Stowe
Psychemedics Corporation 5832 Uplander Way Culver City,  CA  90230
Product CodeLAF  
CFR Regulation Number862.3610 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-27
Decision Date2021-12-15

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.