The following data is part of a premarket notification filed by Abbott Ireland Diagnostics Division with the FDA for Albumin Bcp2.
| Device ID | K203530 |
| 510k Number | K203530 |
| Device Name: | Albumin BCP2 |
| Classification | Bromcresol Purple Dye-binding, Albumin |
| Applicant | Abbott Ireland Diagnostics Division Lisnamuck Longford, IE |
| Contact | Suzanne Cheang |
| Correspondent | Suzanne Cheang Abbott Ireland Diagnostics Division Lisnamuck Longford, IE |
| Product Code | CJW |
| CFR Regulation Number | 862.1035 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-12-02 |
| Decision Date | 2022-03-18 |