VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator— 510(k) DEN210038

Name: FDA 510(k) clearance DEN210038
Creator: U.S. Food and Drug Administration
Published: 2023-05-05

Unknown

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance DEN210038 for VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator, Unknown on 2023-05-05. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code QVP
Device class: Class 2
Regulation: 21 CFR 866.3983
Advisory panel: Microbiology
Date received: 2021-09-20
Decision date: 2023-05-05
Decision: Unknown
Clearance type: Direct
Location: Rochester, NY, US

View on FDA.gov ↗

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