K905486 is an FDA 510(k) clearance for the IMMUNOWELL TPO (MICROSOME) TEST. This device is classified as a Immunochemical, Thyroglobulin Autoantibody (Class II - Special Controls, product code JNL).
Submitted by General Biometrics, Inc. (San Diego, US). The FDA issued a Cleared decision on January 3, 1991, 28 days after receiving the submission on December 6, 1990.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5870.
| 510(k) Number | K905486 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 06, 1990 |
| Decision Date | January 03, 1991 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Immunology (IM) |
| Summary | — |
| Product Code | JNL — Immunochemical, Thyroglobulin Autoantibody |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.5870 |