PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR

Enzyme Immunoassay, Opiates

PSYCHEMEDICS CORP.

The following data is part of a premarket notification filed by Psychemedics Corp. with the FDA for Psychemedics Analysis Of Morphine In Hair.

Pre-market Notification Details

Device IDK000851
510k NumberK000851
Device Name:PSYCHEMEDICS ANALYSIS OF MORPHINE IN HAIR
ClassificationEnzyme Immunoassay, Opiates
Applicant PSYCHEMEDICS CORP. 1280 MASSACHUSETTS AVE. SUITE 200 Cambridge,  MA  02138
ContactWilliam Thistle
CorrespondentWilliam Thistle
PSYCHEMEDICS CORP. 1280 MASSACHUSETTS AVE. SUITE 200 Cambridge,  MA  02138
Product CodeDJG  
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-03-15
Decision Date2000-12-11

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