The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Cortisol And Cortisol Calibrators On The Access Immunoassay Systems.
| Device ID | K050202 |
| 510k Number | K050202 |
| Device Name: | CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Brent Taber |
| Correspondent | Brent Taber BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | CGR |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-28 |
| Decision Date | 2005-02-09 |
| Summary: | summary |