FDA 510(k) Application Details - K082661

Device Classification Name	Antigens, All Groups, Streptococcus Spp.   More FDA Info for this Device
510(K) Number	K082661
Device Name	Antigens, All Groups, Streptococcus Spp.
Applicant	PRINCETON BIOMEDITECH CORP. 4242 U.S. RT. 1 MONMOUTH JUNCTION, NJ 08852-1905 US Other 510(k) Applications for this Company
Contact	KYUNG-AH KIM 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	09/12/2008
Decision Date	10/06/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review