Psychemedics Homogeneous Enzyme Immunoassay For Cocaine In Hair

Enzyme Immunoassay, Cocaine

Psychemedics Corporation

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

Pre-market Notification Details

Device IDK201228
510k NumberK201228
Device Name:Psychemedics Homogeneous Enzyme Immunoassay For Cocaine In Hair
ClassificationEnzyme Immunoassay, Cocaine
Applicant Psychemedics Corporation 5832 Uplander Way Culver City,  CA  90230
ContactNeil Stowe
CorrespondentNeil Stowe
Psychemedics Corporation 5832 Uplander Way Culver City,  CA  90230
Product CodeJXO  
CFR Regulation Number862.3250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-07
Decision Date2021-06-25

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