FDA 510(k) Application Details - K070068

Device Classification Name	Electrode, Ion Based, Enzymatic, Creatinine   More FDA Info for this Device
510(K) Number	K070068
Device Name	Electrode, Ion Based, Enzymatic, Creatinine
Applicant	NOVA BIOMEDICAL CORP. 200 PROSPECT ST. WALTHAM, MA 02454-9141 US Other 510(k) Applications for this Company
Contact	PAUL W MACDONALD,PHD Other 510(k) Applications for this Contact
Regulation Number	862.1225   More FDA Info for this Regulation Number
Classification Product Code	CGL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/08/2007
Decision Date	05/07/2007
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