The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Thyroglobulin Antibody And Calibrators On The Access Immunoassay Systems, Models 33890, 33895.
| Device ID | K012208 |
| 510k Number | K012208 |
| Device Name: | ACCESS THYROGLOBULIN ANTIBODY AND CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 33890, 33895 |
| Classification | Thyroglobulin, Antigen, Antiserum, Control |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Denise Thompson |
| Correspondent | Denise Thompson BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | DDC |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-16 |
| Decision Date | 2001-09-07 |
| Summary: | summary |