FDA 510(k) Application Details - DEN210038

Device Classification Name	More FDA Info for this Device
510(K) Number	DEN210038
Device Name	VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
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	09/20/2021
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