FDA 510(k) Application Details - K973692

Device Classification Name	C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K973692
Device Name	C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	UNITED BIOTECH, INC. 110 PIONEER WAY, #C MOUNTAIN VIEW, CA 94041-1517 US Other 510(k) Applications for this Company
Contact	CHIN SHU CHENG 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	09/26/1997
Decision Date	02/09/1998
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