FDA 510(k) Application Details - K051638

Device Classification Name	Antigens, All Groups, Streptococcus Spp.   More FDA Info for this Device
510(K) Number	K051638
Device Name	Antigens, All Groups, Streptococcus Spp.
Applicant	UNIPATH LTD. PRIORY BUSINESS PARK BEDFORD MK44 3UP GB Other 510(k) Applications for this Company
Contact	Louise Roberts Other 510(k) Applications for this Contact
Regulation Number	866.3740   More FDA Info for this Regulation Number
Classification Product Code	GTY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/20/2005
Decision Date	12/06/2005
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