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FDA 510(k) Application Details - K220963
Device Classification Name
More FDA Info for this Device
510(K) Number
K220963
Device Name
Simplexa COVID-19 & Flu A/B Direct
Applicant
DiaSorin Molecular LLC
11331 Valley View Street
Cypress, CA 90630 US
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Contact
Sharon Young
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Regulation Number
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Classification Product Code
QOF
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More FDA Info for this Product Code
Date Received
04/01/2022
Decision Date
03/17/2023
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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