FDA 510(k) Application Details - K012312

Device Classification Name	Radioimmunoassay, Tobramycin   More FDA Info for this Device
510(K) Number	K012312
Device Name	Radioimmunoassay, Tobramycin
Applicant	DIAGNOSTIC PRODUCTS CORP. 5700 WEST 96TH ST. LOS ANGELES, CA 90045-5597 US Other 510(k) Applications for this Company
Contact	EDWARD M LEVINE 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	07/23/2001
Decision Date	08/20/2001
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