K071219 is an FDA 510(k) clearance for the ATHENA MULTI-LYTE GBM TEST SYSTEM. This device is classified as a Devices, Measure, Antibodies To Glomerular Basement Membrane (gbm) (Class II - Special Controls, product code MVJ).
Submitted by Zeus Scientific, Inc. (Branchburg, US). The FDA issued a Cleared decision on December 6, 2007, 218 days after receiving the submission on May 2, 2007.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5660.
| 510(k) Number | K071219 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 02, 2007 |
| Decision Date | December 06, 2007 |
| Days to Decision | 218 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 |