FDA 510(k) Application Details - K132711

Device Classification Name	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl   More FDA Info for this Device
510(K) Number	K132711
Device Name	Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
Applicant	CAROLINA LIQUID CHEMISTRIES CORP. 575 N. PATTERSON AVE. SUITE 430 WINSTON-SALEM, NC 27101 US Other 510(k) Applications for this Company
Contact	PHILIP G SHUGART Other 510(k) Applications for this Contact
Regulation Number	862.1475   More FDA Info for this Regulation Number
Classification Product Code	LBS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/29/2013
Decision Date	05/08/2014
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