510(k) K042838 ยท JIT Calibrator, Secondary
VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 9, 2004 |
| Received | Oct 14, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K042838
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.