K223405 is an FDA 510(k) clearance for the Access Testosterone. This device is classified as a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I - General Controls, product code CDZ).
Submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on January 13, 2023, 65 days after receiving the submission on November 9, 2022.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1680.
| 510(k) Number | K223405 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 2022 |
| Decision Date | January 13, 2023 |
| Days to Decision | 65 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 |