The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Access Tsh (3rd Is) Assay, Dxi 9000 Access Immunoassay Analyzer.
| Device ID | K221225 |
| 510k Number | K221225 |
| Device Name: | Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer |
| Classification | Radioimmunoassay, Thyroid-stimulating Hormone |
| Applicant | Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 |
| Contact | Kuljeet Kaur |
| Correspondent | Kuljeet Kaur Beckman Coulter, Inc. 1000 Lake Hazeltine Drive Chaska, MN 55318 |
| Product Code | JLW |
| CFR Regulation Number | 862.1690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-28 |
| Decision Date | 2022-11-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590744373 | K221225 | 000 |