The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Ferritin On The Access Immunoassay Systems, Model 33020.
| Device ID | K052082 |
| 510k Number | K052082 |
| Device Name: | FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020 |
| Classification | Radioimmunoassay (two-site Solid Phase), Ferritin |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Carolyn Anderson |
| Correspondent | Carolyn Anderson BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | JMG |
| CFR Regulation Number | 866.5340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-02 |
| Decision Date | 2005-08-19 |
| Summary: | summary |