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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
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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
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