The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Ultrasensitive Hgh Calibrator, Model 33585.
| Device ID | K061282 |
| 510k Number | K061282 |
| Device Name: | ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585 |
| Classification | Calibrator, Secondary |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Jennifer Ruether |
| Correspondent | Jennifer Ruether BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-08 |
| Decision Date | 2006-06-02 |
| Summary: | summary |