FDA 510(k) Application Details - K972012

Device Classification Name	Urease, Photometric, Urea Nitrogen   More FDA Info for this Device
510(K) Number	K972012
Device Name	Urease, Photometric, Urea Nitrogen
Applicant	CHOLESTECH CORP. 3347 INVESTMENT BLVD. HAYWARD, CA 94545 US Other 510(k) Applications for this Company
Contact	GARY HEWETT Other 510(k) Applications for this Contact
Regulation Number	862.1770   More FDA Info for this Regulation Number
Classification Product Code	CDN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/30/1997
Decision Date	07/24/1997
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