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FDA 510(k) Application Details - K223591
Device Classification Name
More FDA Info for this Device
510(K) Number
K223591
Device Name
cobas« SARS-CoV-2 & Influenza A/B for use on the cobas« Liat System
Applicant
Roche Molecular Systems, Inc.
4300 Hacienda Drive
Pleasanton, CA 94588-2722 US
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Contact
Aradhana Karthikeyan
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QOF
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/01/2022
Decision Date
07/27/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Dual Track
Reviewed By Third Party
N
Expedited Review
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