510(k) K940006 ยท JLW Radioimmunoassay, Thyroid-Stimulating Hormone
IMMULITE THIRD GENERATION (MODIFICATION)
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Dec 19, 1994 |
| Received | Jan 6, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940006
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2013 | Siemens Healthcare Diagnostics, Inc IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T).
Intended to quantitatively measure human thyroid stimulating hormone (TSH, thyrotropin). Terminated |
JLW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.