FDA 510(k) Application Details - K023556

Device Classification Name	More FDA Info for this Device
510(K) Number	K023556
Device Name	FLU OIA A/B TEST KIT
Applicant	THERMO BIOSTAR, INC. 331 SOUTH 104 ST. LOUISVILLE, CO 80027 US Other 510(k) Applications for this Company
Contact	JOHN G ADAMS 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	10/23/2002
Decision Date	03/27/2003
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