FDA 510(k) Application Details - K132726

Device Classification Name	More FDA Info for this Device
510(K) Number	K132726
Device Name	ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM
Applicant	PRIMERADX 171 FORBES BLVD SUITE 1000 MANSFIELD, MA 02048 US Other 510(k) Applications for this Company
Contact	FAYYAZ MEMNON Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/30/2013
Decision Date	11/29/2013
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	MI - Microbiology
Review Advisory Committee	MI - Microbiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review