PSYCHEMEDICS OPIATES EIA


Device Classification Name

enzyme immunoassay, opiates

510(k) Number K111926
Device Name PSYCHEMEDICS OPIATES 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 862.3650
Classification Product Code
DJG  
Date Received 07/06/2011
Decision Date 05/01/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No