K954256 is an FDA 510(k) clearance for the ANTI-TPO. This device is classified as a Immunochemical, Thyroglobulin Autoantibody (Class II - Special Controls, product code JNL).
Submitted by Biomerica, Inc. (Newport Beach, US). The FDA issued a Cleared decision on November 27, 1995, 83 days after receiving the submission on September 5, 1995.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K954256 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 1995 |
| Decision Date | November 27, 1995 |
| Days to Decision | 83 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | JNL - Immunochemical, Thyroglobulin Autoantibody |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5870 |