510(k) K994145 ยท JIS Calibrator, Primary
VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS
| Applicant | Ortho-Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Dec 22, 1999 |
| Received | Dec 8, 1999 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K994145
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2024 | QUIDELORTHO VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin).
Product Code: 131 5589 Open, Classified |
CDP | None listed |
| May 14, 2024 | QUIDELORTHO VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or hepari Open, Classified |
JIS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.