K000287 is an FDA 510(k) clearance for the BRAHMS DIAGNOSTICA LUMITEST ANTI-TPO. This device is classified as a System, Test, Thyroid Autoantibody (Class II - Special Controls, product code JZO).
Submitted by Brahms Diagnostica, LLC (Norcross, US). The FDA issued a Cleared decision on March 17, 2000, 46 days after receiving the submission on January 31, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K000287 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 31, 2000 |
| Decision Date | March 17, 2000 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JZO — System, Test, Thyroid Autoantibody |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5870 |