FDA 510(k) Application Details - K011275

Device Classification Name	Radioimmunoassay, Phencyclidine   More FDA Info for this Device
510(K) Number	K011275
Device Name	Radioimmunoassay, Phencyclidine
Applicant	PSYCHEMEDICS CORP. 5832 UPLANDER WAY CULVER CITY, CA 90230 US Other 510(k) Applications for this Company
Contact	THOMAS CAIRNS Other 510(k) Applications for this Contact
Regulation Number	000.0000   More FDA Info for this Regulation Number
Classification Product Code	LCL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/26/2001
Decision Date	02/11/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	-
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review