PSYCHEMEDICS RIA COCAINE ASSAY


Device Classification Name

radioimmunoassay, cocaine metabolite

510(k) Number K010868
Device Name PSYCHEMEDICS RIA COCAINE ASSAY
Original Applicant
PSYCHEMEDICS CORP.
5832 uplander way
culver city, 
CA 
90230

Original Contact thomas cairns
Regulation Number 862.3250
Classification Product Code
KLN  
Date Received 03/23/2001
Decision Date 11/06/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized