K983553 is an FDA 510(k) clearance for the ANTI-TG IGG ELISA TEST SYSTEM. This device is classified as a System, Test, Thyroid Autoantibody (Class II - Special Controls, product code JZO).
Submitted by Columbia Bioscience, Inc. (Columbia, US). The FDA issued a Cleared decision on December 7, 1998, 59 days after receiving the submission on October 9, 1998.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K983553 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 09, 1998 |
| Decision Date | December 07, 1998 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JZO — System, Test, Thyroid Autoantibody |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5870 |