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FDA 510(k) Application Details - K222779
Device Classification Name
Real Time Nucleic Acid Amplification System
More FDA Info for this Device
510(K) Number
K222779
Device Name
Real Time Nucleic Acid Amplification System
Applicant
Meridian Bioscience, Inc
3471 River Hills Drive
Cincinnati, OH 45244 US
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Contact
Jack Rogers
Other 510(k) Applications for this Contact
Regulation Number
862.2570
More FDA Info for this Regulation Number
Classification Product Code
OOI
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More FDA Info for this Product Code
Date Received
09/14/2022
Decision Date
01/26/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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