PSYCHEMEDICS PHENCYCLIDINE EIA


Device Classification Name

enzyme immunoassay, phencyclidine

510(k) Number K111928
Device Name PSYCHEMEDICS PHENCYCLIDINE 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 862.3100
Classification Product Code
LCM  
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