510(k) K983617 ยท LCI Automated Radioimmunoassay Systems, For Clinical Use
25-HYDROXYVITAMIN D 125I RIA KIT
| Applicant | DiaSorin, Inc., Columbia MD, US |
| Decision | Substantially Equivalent, Nov 16, 1998 |
| Received | Oct 15, 1998 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K983617
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2005 | Diasorin Inc. DiaSorin 25-HydroxyvitaminD [125I] RIA Kit. For the quantitative determination of 25-OH-D and other hydroxylated metabolites in serum or plasma. REF: 68100E. DiaSorin Stillwater, Minnesota 55082-02 Terminated |
LCI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.