FDA 510(k) Application Details - K040332

Device Classification Name	Analyzer, Chemistry, Micro, For Clinical Use   More FDA Info for this Device
510(K) Number	K040332
Device Name	Analyzer, Chemistry, Micro, For Clinical Use
Applicant	ARKRAY, 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	862.2170   More FDA Info for this Regulation Number
Classification Product Code	JJF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/10/2004
Decision Date	06/16/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review