FDA 510(k) Application Details - K962609

Device Classification Name	Instrument For Auto Reader Of Overnight Microorganism Identification System   More FDA Info for this Device
510(K) Number	K962609
Device Name	Instrument For Auto Reader Of Overnight Microorganism Identification System
Applicant	BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 US Other 510(k) Applications for this Company
Contact	DAVID K BROADWAY Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	LRH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/03/1996
Decision Date	08/30/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review