510(k) K984619 ยท MVJ Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm)
BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT
| Applicant | The Binding Site, Ltd., Santa Monica CA, US |
| Decision | Substantially Equivalent, Feb 23, 1999 |
| Received | Dec 29, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984619
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.