FDA 510(k) Application Details - K041408

Device Classification Name	Automated Occult Blood Analyzer   More FDA Info for this Device
510(K) Number	K041408
Device Name	Automated Occult Blood Analyzer
Applicant	POLYMEDCO, INC. 510 FURNACE DOCK RD. CORTLANDT MANOR, NY 10567 US Other 510(k) Applications for this Company
Contact	HELEN LANDICHO Other 510(k) Applications for this Contact
Regulation Number	864.6550   More FDA Info for this Regulation Number
Classification Product Code	OOX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/27/2004
Decision Date	10/21/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HE - Hematology
Review Advisory Committee	HE - Hematology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review