FDA 510(k) Application Details - K021172

Device Classification Name	Antisera, Cf, Poliovirus 1-3   More FDA Info for this Device
510(K) Number	K021172
Device Name	Antisera, Cf, Poliovirus 1-3
Applicant	THERMO BIOSTAR, INC. 6655 LOOKOUT RD. BOULDER, CO 80301 US Other 510(k) Applications for this Company
Contact	KOHN G ADAMS Other 510(k) Applications for this Contact
Regulation Number	866.3405   More FDA Info for this Regulation Number
Classification Product Code	GOG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/12/2002
Decision Date	09/13/2002
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