FDA 510(k) Application Details - K132491

Device Classification Name	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth   More FDA Info for this Device
510(K) Number	K132491
Device Name	Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Applicant	EDGE BIOLOGICALS, INC. 598 NORTH SECOND ST. MEMPHIS, TN 38105 US Other 510(k) Applications for this Company
Contact	TED A PEARSON Other 510(k) Applications for this Contact
Regulation Number	866.1700   More FDA Info for this Regulation Number
Classification Product Code	JTZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/08/2013
Decision Date	06/30/2014
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