The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Thyroglobulin Anitbody.
| Device ID | K112933 |
| 510k Number | K112933 |
| Device Name: | ACCESS THYROGLOBULIN ANITBODY |
| Classification | Immunochemical, Thyroglobulin Autoantibody |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Geraldine L Baglien |
| Correspondent | Geraldine L Baglien BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Product Code | JNL |
| CFR Regulation Number | 866.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-03 |
| Decision Date | 2011-12-27 |
| Summary: | summary |