FDA 510(k) Application Details - K952095

Device Classification Name	Gram Positive Identification Panel   More FDA Info for this Device
510(K) Number	K952095
Device Name	Gram Positive Identification Panel
Applicant	BIOMERIEUX VITEK, INC. 595 ANGLUM DR. HAZELWOOD, MO 63042-2395 US Other 510(k) Applications for this Company
Contact	CHERYL WINTERS-HEARD Other 510(k) Applications for this Contact
Regulation Number	866.2660   More FDA Info for this Regulation Number
Classification Product Code	LQL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/1995
Decision Date	03/12/1996
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