510(k) K023304 ยท JKR Radioimmunoassay, Calcitonin
IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Dec 9, 2002 |
| Received | Oct 3, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023304
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2014 | Siemens Healthcare Diagnostics, Inc. IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi)
For in vitro diagnostic use with IMMULITE Systems Analyzers for the quantitative measurement of calcito Terminated |
JJY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.