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FDA 510(k) Application Details - K133673
Device Classification Name
More FDA Info for this Device
510(K) Number
K133673
Device Name
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA
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
OZZ
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/29/2013
Decision Date
03/25/2014
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
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