510(k) K982468 ยท MSW System, Test, Thyroglobulin
IMMULITE 2000 THYROGLOBULIN MODEL L2KTY
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Mar 12, 1999 |
| Received | Jul 15, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K982468
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 11, 2023 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers (IMMULITE 2000/ IMMULITE 2000 XPi) for the quantitative measurement of thyroglobulin in serum o Open, Classified |
MSW | None listed |
| Jan 11, 2023 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers for the quantitative measurement of thyroglobulin in serum or heparinized plasma, as an aid in Open, Classified |
MSW | None listed |
| May 4, 2018 | Siemens Healthcare Diagnostics, Inc. IMMULITE 2000/IMMULITE 2000 XPi TG Terminated |
MSW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.