The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Testosterone Reagents For Use On The Access Immunoassay Analyzer, Models 33560, 33565.
| Device ID | K001935 |
| 510k Number | K001935 |
| Device Name: | ACCESS TESTOSTERONE REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY ANALYZER, MODELS 33560, 33565 |
| Classification | Radioimmunoassay, Testosterones And Dihydrotestosterone |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Angela M Byland |
| Correspondent | Angela M Byland BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | CDZ |
| CFR Regulation Number | 862.1680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-26 |
| Decision Date | 2000-08-22 |