510(k) K921534 ยท JKL Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry
DSL DHEA (DSL 8900)
| Applicant | Diagnostic Systems Laboratories, Inc., Webster TX, US |
| Decision | Substantially Equivalent, May 26, 1992 |
| Received | Mar 31, 1992 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K921534
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 26, 2011 | Beckman Coulter Inc. DHEA RIA Reagent
The DSL8900 DHEA radioimmunoassay is intended for quantitative determination of dehydroepiandrosterone in serum or plasma. This assay is intended for in vitro diagnostic use. Terminated |
JKC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.