510(k) K082129 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Feb 10, 2009 |
| Received | Jul 29, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K082129
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 13, 2018 | The Binding Site Group, Ltd. Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S
The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on st Terminated |
CFN | None listed |
| Nov 17, 2018 | The Binding Site Group, Ltd. Binding Site Human IgM Kit (for SPAPLUS), REF: NK012.S
The device consists of reaction buffer, sheep anti-IgM antiserum, six calibrators and two controls. The calibrators and controls are based on st Terminated |
CFN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.