510(k) K970016 ยท CDP Radioimmunoassay, Total Triiodothyronine
VITROS IMMUNODIAGNOSITCS PRODUCTS-FREE T3 REAGENT PACK (GEM.1020)/FREE T3 CALIBRATORS (GEM.C020)
| Applicant | Johnson & Johnson Clinical Diagnostics, Inc., Rochester NY, US |
| Decision | Substantially Equivalent, Jan 30, 1997 |
| Received | Jan 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K970016
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.