FDA 510(k) Application Details - K991834

Device Classification Name	Hydrazone Colorimetry, Alt/Sgpt   More FDA Info for this Device
510(K) Number	K991834
Device Name	Hydrazone Colorimetry, Alt/Sgpt
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	862.1030   More FDA Info for this Regulation Number
Classification Product Code	CKD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/1999
Decision Date	09/09/1999
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