K000363 is an FDA 510(k) clearance for the MODIFICATION TO ZEUS SCIENTIFIC, INC., THYROGLOBULIN IGG ELISA TEST SYSTEM. This device is classified as a Thyroglobulin, Antigen, Antiserum, Control (Class II - Special Controls, product code DDC).
Submitted by Zeus Scientific, Inc. (Raritan, US). The FDA issued a Cleared decision on February 18, 2000, 14 days after receiving the submission on February 4, 2000.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K000363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2000 |
| Decision Date | February 18, 2000 |
| Days to Decision | 14 days |
| Submission Type | Special |
| 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 |