FDA 510(k) Application Details - K133710

Device Classification Name	Calibrators, Drug Mixture   More FDA Info for this Device
510(K) Number	K133710
Device Name	Calibrators, Drug Mixture
Applicant	Lin-Zhi International, Inc. 670 ALMANOR AVE SUNNYVALE, CA 94085 US Other 510(k) Applications for this Company
Contact	BERNICE LIN Other 510(k) Applications for this Contact
Regulation Number	862.3200   More FDA Info for this Regulation Number
Classification Product Code	DKB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/04/2013
Decision Date	02/21/2014
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review