K203530 is an FDA 510(k) clearance for the Albumin BCP2. This device is classified as a Bromcresol Purple Dye-binding, Albumin (Class II - Special Controls, product code CJW).
Submitted by Abbott Ireland Diagnostics Division (Longford, IE). The FDA issued a Cleared decision on March 18, 2022, 471 days after receiving the submission on December 2, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1035.
| 510(k) Number | K203530 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 02, 2020 |
| Decision Date | March 18, 2022 |
| Days to Decision | 471 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CJW - Bromcresol Purple Dye-binding, Albumin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1035 |