The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Thyroglobulin Antibody Ii Assay, Models A32898 (reagent) And A36920 (calibrators).
| Device ID | K062516 |
| 510k Number | K062516 |
| Device Name: | ACCESS THYROGLOBULIN ANTIBODY II ASSAY, MODELS A32898 (REAGENT) AND A36920 (CALIBRATORS) |
| Classification | Immunochemical, Thyroglobulin Autoantibody |
| Applicant | BECKMAN COULTER, INC. 1000 LAKE HAZELTINE DR. Chaska, MN 55318 -1084 |
| Contact | Tyler Foutch |
| Correspondent | Tyler Foutch 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 | 2006-08-28 |
| Decision Date | 2006-10-05 |
| Summary: | summary |