FDA 510(k) Application Details - K971349

Device Classification Name	Antigens, All Groups, Streptococcus Spp.   More FDA Info for this Device
510(K) Number	K971349
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	JEMO KANG 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	04/10/1997
Decision Date	07/07/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review