510(k) K950228 ยท CFL Radioimmunoassay, Human Growth Hormone
DSL ACTIVE IGFBP-3 IRMA (DSL 6600)
| Applicant | Diagnostic Systems Laboratories, Inc., Webster TX, US |
| Decision | Substantially Equivalent, Feb 22, 1995 |
| Received | Jan 11, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K950228
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 28, 2010 | Beckman Coulter Inc. IGFBP-3 Immunoradiometric Assay (IRMA) Kit, Part
Number: DSL-6600
usage: The DSL6600 IGFBP-3 immunoradiometric assay (IRMA) kit provides materials for the quantitative measurement of IGFBP-3 in seru Terminated |
CFL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.