510(k) K955440 ยท CDZ Radioimmunoassay, Testosterones And Dihydrotestosterone
IMMULITE SHBG (MODIFICATION)
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Dec 21, 1995 |
| Received | Oct 23, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955440
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2017 | Siemens Healthcare Diagnostics, Inc. SHBG IMMULITE 2000/IMMULITE 2000 XPi
For the in vitro diagnostic use with the IMMULITE 2000 Systems Analyzers-For the quantitative measurement of SHBG in serum, as aid in the differential diagnosis of Terminated |
CDZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.