K223867 is an FDA 510(k) clearance for the IDS ACTH II. This device is classified as a Radioimmunoassay, Acth (Class II - Special Controls, product code CKG).
Submitted by Immunodiagnostic Systems Limited (Boldon, GB). The FDA issued a Cleared decision on August 18, 2023, 238 days after receiving the submission on December 23, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1025.
| 510(k) Number | K223867 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 23, 2022 |
| Decision Date | August 18, 2023 |
| Days to Decision | 238 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CKG - Radioimmunoassay, Acth |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1025 |