K936010 is an FDA 510(k) clearance for the THYROGLOBULIN AUTOANTIBODY ENZYME IMMUNOASSAY. This device is classified as a Thyroglobulin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDC).
Submitted by Biomerica, Inc. (Newport Beach, US). The FDA issued a Cleared decision on July 18, 1994, 214 days after receiving the submission on December 16, 1993.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K936010 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 1993 |
| Decision Date | July 18, 1994 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Statement |
| Product Code | DDC - Thyroglobulin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5870 |