K201908 is an FDA 510(k) clearance for the LIAISON Testosterone xt. This device is classified as a Radioimmunoassay, Testosterones And Dihydrotestosterone (Class I - General Controls, product code CDZ).
Submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on October 15, 2020, 98 days after receiving the submission on July 9, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1680.
| 510(k) Number | K201908 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 09, 2020 |
| Decision Date | October 15, 2020 |
| Days to Decision | 98 days |
| Submission Type | Special |
| 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 |