K991610 is an FDA 510(k) clearance for the ZEUS SCIENTIFIC INC., TPO 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. (Branchburg, US). The FDA issued a Cleared decision on June 25, 1999, 46 days after receiving the submission on May 10, 1999.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K991610 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 10, 1999 |
| Decision Date | June 25, 1999 |
| Days to Decision | 46 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 |