510(k) K022901 ยท JIS Calibrator, Primary
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS
| Applicant | Ortho-Clinical Diagnostics, Rochester NY, US |
| Decision | Substantially Equivalent, Sep 27, 2002 |
| Received | Sep 3, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K022901
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.