FDA 510(k) Application Details - K020692

Device Classification Name	Radioimmunoassay, Vancomycin   More FDA Info for this Device
510(K) Number	K020692
Device Name	Radioimmunoassay, Vancomycin
Applicant	DADE BEHRING, INC. 514 GBC DR. NEWARK, DE 19702 US Other 510(k) Applications for this Company
Contact	DONNA A WOLF Other 510(k) Applications for this Contact
Regulation Number	862.3950   More FDA Info for this Regulation Number
Classification Product Code	LEH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/04/2002
Decision Date	05/10/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review