The following data is part of a premarket notification filed by Beckman Coulter Ireland Inc. with the FDA for Beta-2-microglobulin.
| Device ID | K161297 |
| 510k Number | K161297 |
| Device Name: | Beta-2-Microglobulin |
| Classification | System, Test, Beta-2-microglobulin Immunological |
| Applicant | Beckman Coulter Ireland Inc. Lismeehan, O'Callaghan's Mills Co. Clare, IE |
| Contact | Eimear Carr |
| Correspondent | Eimear Carr Beckman Coulter Ireland Inc. Lismeehan, O'Callaghan's Mills Co. Clare, IE |
| Product Code | JZG |
| CFR Regulation Number | 866.5630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-09 |
| Decision Date | 2016-06-07 |
| Summary: | summary |