FDA 510(k) Application Details - K142366

Device Classification Name	Culture Media, Non-Propagating Transport   More FDA Info for this Device
510(K) Number	K142366
Device Name	Culture Media, Non-Propagating Transport
Applicant	PURITAN MEDICAL PRODUCTS LLC 31 SCHOOL STREET P.O. BOX 149 GUILFORD, ME 04443 US Other 510(k) Applications for this Company
Contact	Mehdi Karamchi Other 510(k) Applications for this Contact
Regulation Number	866.2390   More FDA Info for this Regulation Number
Classification Product Code	JSM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/25/2014
Decision Date	01/09/2015
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