FDA 510(k) Application Details - K033548

Device Classification Name	Reagent, Occult Blood   More FDA Info for this Device
510(K) Number	K033548
Device Name	Reagent, Occult Blood
Applicant	ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. INDIANAPOLIS, IN 46250 US Other 510(k) Applications for this Company
Contact	JENNIFER TRIBBETT Other 510(k) Applications for this Contact
Regulation Number	864.6550   More FDA Info for this Regulation Number
Classification Product Code	KHE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2003
Decision Date	11/24/2003
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review