510(k) K042475 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
VITROS CHEMISTRY PRODUCTS IGG, IGA AND IGM REAGENTS; VITROS CHEMISTRY PRODUCT CALIBRATOR KIT 20; VITROS CHEMISTRY PRODUC
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Nov 10, 2004 |
| Received | Sep 13, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042475
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.