510(k) DEN210038 ยท QVP Sars-Cov-2 Serology Test
VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Reagent Pack, VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Unknown, May 5, 2023 |
| Received | Sep 20, 2021 |
| Type | Direct |
| FDA record | Open on fda.gov |
Recalls that name DEN210038
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.