FDA 510(k) Application Details - K981651

Device Classification Name	More FDA Info for this Device
510(K) Number	K981651
Device Name	AB FLU OIA
Applicant	BIOSTAR, INC. 6655 LOOKOUT RD. BOULDER, CO 80301 US Other 510(k) Applications for this Company
Contact	ROGER C BRIDEN Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PSZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/11/1998
Decision Date	11/25/1998
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