510(k) K070391 ยท CEW Radioimmunoassay, Parathyroid Hormone
ELECSYS PTH TEST SYSTEM
| Applicant | Roche Diagnostics Corp., Indianapolis IN, US |
| Decision | Substantially Equivalent, Mar 20, 2007 |
| Received | Feb 9, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070391
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.