FDA 510(k) Application Details - K972609

Device Classification Name	Fluorescent Immunoassay Gentamicin   More FDA Info for this Device
510(K) Number	K972609
Device Name	Fluorescent Immunoassay Gentamicin
Applicant	BIO-RAD 4000 ALFRED NOBEL DR. HERCULES, CA 94547-1803 US Other 510(k) Applications for this Company
Contact	JOHN W NELSON Other 510(k) Applications for this Contact
Regulation Number	862.3450   More FDA Info for this Regulation Number
Classification Product Code	LCQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/11/1997
Decision Date	08/06/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review