FDA 510(k) Application Details - K093297

Device Classification Name	Acid, Lactic, Enzymatic Method   More FDA Info for this Device
510(K) Number	K093297
Device Name	Acid, Lactic, Enzymatic Method
Applicant	EPOCAL, INC. 2060 WALKLEY RD. OTTAWA, ONTARIO K1G-3P5 CA Other 510(k) Applications for this Company
Contact	ROY LAYER 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	10/21/2009
Decision Date	06/09/2010
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