FDA 510(k) Application Details - K050790

Device Classification Name	Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase   More FDA Info for this Device
510(K) Number	K050790
Device Name	Tetrazolium Int Dye-Diaphorase, Lactate Dehydrogenase
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	862.1440   More FDA Info for this Regulation Number
Classification Product Code	CFH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/28/2005
Decision Date	06/06/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CH - Clinical Chemistry
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review