FDA 510(k) Application Details - K961042

Device Classification Name	Instrument For Auto Reader Of Overnight Microorganism Identification System   More FDA Info for this Device
510(K) Number	K961042
Device Name	Instrument For Auto Reader Of Overnight Microorganism Identification System
Applicant	DADE MICROSCAN, INC. 1584 ENTERPRISE BLVD. WEST SACRAMENTO, CA 95691 US Other 510(k) Applications for this Company
Contact	SHAROLYN J LENTSCH 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	03/14/1996
Decision Date	05/30/1996
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