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FDA 510(k) Application Details - DEN210040
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN210040
Device Name
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 Total Calibrators
Applicant
Ortho-Clinical Diagnostics, Inc.
100 Indigo Creek Drive
Rochester, NY 14626 US
Other 510(k) Applications for this Company
Contact
Marlene Hanna
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QVP
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/21/2021
Decision Date
05/05/2023
Decision
DENG -
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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