FDA 510(k) Application Details - K100602

Device Classification Name	Acid, Lactic, Enzymatic Method   More FDA Info for this Device
510(K) Number	K100602
Device Name	Acid, Lactic, Enzymatic Method
Applicant	NOVA BIOMEDICAL CORP. 200 PROSPECT ST. WALTHAM, MA 02454-9141 US Other 510(k) Applications for this Company
Contact	PAUL W MACDONALD Other 510(k) Applications for this Contact
Regulation Number	862.1450   More FDA Info for this Regulation Number
Classification Product Code	KHP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/03/2010
Decision Date	08/17/2011
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