FDA 510(k) Application Details - K003341

Device Classification Name	Radioimmunoassay, Tobramycin   More FDA Info for this Device
510(K) Number	K003341
Device Name	Radioimmunoassay, Tobramycin
Applicant	SYVA CO., DADE BEHRING, INC. P.O. BOX 49013 3403 YERBA BUENA ROAD SAN JOSE, CA 95161-9013 US Other 510(k) Applications for this Company
Contact	PAUL L ROGER Other 510(k) Applications for this Contact
Regulation Number	862.3900   More FDA Info for this Regulation Number
Classification Product Code	KLB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/25/2000
Decision Date	01/22/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review