K023592 is an FDA 510(k) clearance for the SERAQUEST ANTI-THYROGLOBULIN. This device is classified as a Thyroglobulin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDC).
Submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on January 6, 2003, 73 days after receiving the submission on October 25, 2002.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K023592 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 25, 2002 |
| Decision Date | January 06, 2003 |
| Days to Decision | 73 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | DDC — Thyroglobulin, Antigen, Antiserum, Control |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5870 |