510(k) K032881 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Oct 10, 2003 |
| Received | Sep 15, 2003 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K032881
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2022 | Siemens Healthcare Diagnostics, Inc. IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and IMMULITE 1000 Analyzers for the quantitative measurement of total testosterone in serum and hepariniz Open, Classified |
CDZ | None listed |
| Feb 16, 2006 | Diagnostic Products Corp. IMMULITE 2000 Total Testosterone Kit Terminated |
CDZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.