510(k) K070900 ยท DFH Kappa, Antigen, Antiserum, Control
FREELITE HUMAN KAPPA AND LAMBDA FREE DIAGNOSTIC TEST KITS FOR USE ON THE ROCHE COBAS INTEGRA 400/400 PLUS ANALYZER KIT
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Nov 30, 2007 |
| Received | Apr 2, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070900
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2021 | The Binding Site Group, Ltd. FREELITE Human Kappa Free Kit for use on the Roche cobas c Systems, Kappa Freie Leichtkette (Human) kit for Roche cobas c Systems, REF: LK016.CB, IVD CE, UDI: 05051700012096 Terminated |
DFH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.