FDA 510(k) Application Details - K992311

Device Classification Name	C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K992311
Device Name	C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	KAMIYA BIOMEDICAL CO. 910 INDUSTRY DR. SEATTLE, WA 98188-3412 US Other 510(k) Applications for this Company
Contact	COLIN GETTY 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	07/09/1999
Decision Date	09/13/1999
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review