K240865 is an FDA 510(k) clearance for the IDS-iSYS Free Testosterone. This device is classified as a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I - General Controls, product code CDZ).
Submitted by Immunodiagnostic Systems Limited (Tyne & Wear, GB). The FDA issued a Cleared decision on October 23, 2024, 209 days after receiving the submission on March 28, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1680.
| 510(k) Number | K240865 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 28, 2024 |
| Decision Date | October 23, 2024 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CDZ - Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1680 |