FDA 510(k) Application Details - K122019

Device Classification Name	More FDA Info for this Device
510(K) Number	K122019
Device Name	STREPTOCOCCUS APP. SEROLOGICAL REAGENTS
Applicant	MERIDIAN BIOSCIENCE, INC. 3471 RIVER HILLS DR. CINCINNATI, OH 45244 US Other 510(k) Applications for this Company
Contact	Michelle L Smith Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OYZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/10/2012
Decision Date	09/13/2012
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