PSYCHEMEDICS METHAMPHETAMINE EIA


Device Classification Name

gas chromatography, methamphetamine

510(k) Number K111927
Device Name PSYCHEMEDICS METHAMPHETAMINE EIA
Applicant
PSYCHEMEDICS CORP.
5832 uplander way
culver city, 
CA 
90230

Applicant Contact virginia hill
Correspondent
PSYCHEMEDICS CORP.
5832 uplander way
culver city, 
CA 
90230

Correspodent Contact virginia hill
Regulation Number 862.3610
Classification Product Code
LAF  
Date Received 07/06/2011
Decision Date 05/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No