510(k) K992680 ยท CEW Radioimmunoassay, Parathyroid Hormone
ELECSYS PARATHYROID HORMONE TEST SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Sep 28, 1999 |
| Received | Aug 10, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K992680
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 16, 2007 | Roche Diagnostics Corp. Roche PTH (parathyroid hormone test system) for use in conjunction with Roche cobas e 411, cobas e 601, Elecsys 1010, Elecsys 2010 and Modular E 170 analyzers; catalog no. 11972103122. Terminated |
CEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.