FDA 510(k) Application Details - K132031

Device Classification Name	Enzymatic Esterase--Oxidase, Cholesterol   More FDA Info for this Device
510(K) Number	K132031
Device Name	Enzymatic Esterase--Oxidase, Cholesterol
Applicant	AXIS-SHIELD POC AS P.O. BOX 6863 RODELOKKA OSLO N-0504 NO Other 510(k) Applications for this Company
Contact	KARI SKINNEMOEN Other 510(k) Applications for this Contact
Regulation Number	862.1175   More FDA Info for this Regulation Number
Classification Product Code	CHH Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/18/2013
Decision Date	03/21/2014
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