K001935 is an FDA 510(k) clearance for the ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565. 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 August 22, 2000, 57 days after receiving the submission on June 26, 2000.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1680.
| 510(k) Number | K001935 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2000 |
| Decision Date | August 22, 2000 |
| Days to Decision | 57 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 |