510(k) K951707 ยท CFL Radioimmunoassay, Human Growth Hormone
DSL ACTIVE IFGBP-3 ELISA
| Applicant | Diagnostic Systems Laboratories, Inc., Webster TX, US |
| Decision | Substantially Equivalent, May 10, 1995 |
| Received | Apr 13, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K951707
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2011 | Beckman Coulter Inc. IGFBP-3 ELISA Reagent Kit; Part Number" DSL-10-6600; Lot Numbers: 992743, 992287, 991916, 991530, 991432, 990220 & 890830
This assay is intended for in vitro diagnostic use. Terminated |
CFL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.