FDA 510(k) Application Details - K011057

Device Classification Name	More FDA Info for this Device
510(K) Number	K011057
Device Name	INTERCEPT ORAL FLUID DRUG TEST ORAL SPECIMEN COLLECTION DEVICE, MODEL 503-XXXX
Applicant	ORASURE TECHNOLOGIES, INC. 150 WEBSTER ST. BETHELEHEM, PA 18015-1389 US Other 510(k) Applications for this Company
Contact	R.SAM NIEDBALA Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PJD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/06/2001
Decision Date	06/06/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review