510(k) K954755 ยท CIZ Radioimmunoassay, Androstenedione
COAT-A-COUNT DIRECT ANDROSTENEDIONE
| Applicant | Diagnostic Products Corp., Los Angeles CA, US |
| Decision | Substantially Equivalent, Nov 29, 1995 |
| Received | Oct 16, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K954755
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 15, 2014 | Siemens Healthcare Diagnostics Inc. Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnostics Terminated |
CIZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.