FDA 510(k) Application Details - K040579

Device Classification Name	C-Reactive Protein, Antigen, Antiserum, And Control   More FDA Info for this Device
510(K) Number	K040579
Device Name	C-Reactive Protein, Antigen, Antiserum, And Control
Applicant	CHOLESTECH CORP. 3347 INVESTMENT BLVD. HAYWARD, CA 94545 US Other 510(k) Applications for this Company
Contact	THOMAS E WORTHY 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	03/04/2004
Decision Date	06/18/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	IM - Immunology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review