510(k) K854650 ยท CIZ Radioimmunoassay, Androstenedione
DSL ACTIVE ANDROSTENEDIONE RIA (DSL #3800)
| Applicant | Diagnostic Systems Laboratories, Inc., Webster TX, US |
| Decision | Substantially Equivalent, Dec 13, 1985 |
| Received | Nov 19, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854650
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2005 | Diasorin Inc. DiaSorin GammaCoat Androstenedione - 125 I, RIA Kit for the quantitative determination of androstenedione levels in serum. Catalog No. CA-1725. Lot # 04164. DiaSorin Stillwater, Minnesota 55082-02 Terminated |
CIZ | None listed |
| Mar 18, 2005 | Diasorin Inc. DiaSorin GammaCoat Androstenedione - [125I] RIA Kit Catalog No. CA-1725, DiaSorin Stillwater, Minnesota 55082-0285, U.S.A. Lot # 05144. for the quantitative determination of androstenedione levels i Terminated |
CIZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.