The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Estradiol Calibrators On The Access Immunoassay Systems, Model 33545.
| Device ID | K080166 |
| 510k Number | K080166 |
| Device Name: | ACCESS ESTRADIOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33545 |
| Classification | Calibrator, Secondary |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Jeffrey L Koll |
| Correspondent | Jeffrey L Koll 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 | 2008-01-23 |
| Decision Date | 2008-03-19 |
| Summary: | summary |