FDA 510(k) Application Details - K972160

Device Classification Name	C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K972160
Device Name	C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	TRINITY LABORATORIES, INC. 7517 PRECISION DR., #107 RALEIGH, NC 27613 US Other 510(k) Applications for this Company
Contact	BRUCE A CLINTON Other 510(k) Applications for this Contact
Regulation Number	866.5270   More FDA Info for this Regulation Number
Classification Product Code	DCK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/09/1997
Decision Date	08/01/1997
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	IM - Immunology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review