FDA 510(k) Application Details - K032027

Device Classification Name	Hydrazone Colorimetry, Ast/Sgot   More FDA Info for this Device
510(K) Number	K032027
Device Name	Hydrazone Colorimetry, Ast/Sgot
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	862.1100   More FDA Info for this Regulation Number
Classification Product Code	CIS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2003
Decision Date	09/05/2003
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