510(k) K974634 ยท CDP Radioimmunoassay, Total Triiodothyronine
IMMULITE FREE T3
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Jan 2, 1998 |
| Received | Dec 12, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K974634
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2014 | Siemens Healthcare Diagnostics T3F, Free T3 Assay, REF/Catalog Number LKF31, Siemens Material Number (SMN) 10381626; an IVD Immunoassay kit for use with the IMMULITE/IMMULITE 1000 Analyzers --- Shipping or unit package: 100, 200, 5 Terminated |
CDP | None listed |
| Jan 30, 2014 | Siemens Healthcare Diagnostics T3F, Free T3 Assay, REF/Catalog Number L2KF32 (200 tests), Siemens Material Number (SMN) 10381675, and REF/Catalog Number L2KF36 (600 Tests), SMN 10381682; an IVD Immunoassay kit for use with the IMMU Terminated |
CDP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.