K991179 is an FDA 510(k) clearance for the 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. (Branchburg, US). The FDA issued a Cleared decision on June 17, 1999, 71 days after receiving the submission on April 7, 1999.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K991179 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 07, 1999 |
| Decision Date | June 17, 1999 |
| Days to Decision | 71 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 |