K984619 is an FDA 510(k) clearance for the BINDING SITE BINDAZYME ANTI-GBM EIA DIAGNOSTIC TEST KIT. This device is classified as a Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm) (Class II - Special Controls, product code MVJ).
Submitted by The Binding Site, Ltd. (Santa Monica, US). The FDA issued a Cleared decision on February 23, 1999, 56 days after receiving the submission on December 29, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K984619 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1998 |
| Decision Date | February 23, 1999 |
| Days to Decision | 56 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | MVJ — Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5660 |