K203248 is an FDA 510(k) clearance for the Albumin BCG2. This device is classified as a Bromcresol Green Dye-binding, Albumin (Class II - Special Controls, product code CIX).
Submitted by Abbott Ireland Diagnostics Division (Longford, IE). The FDA issued a Cleared decision on November 23, 2021, 384 days after receiving the submission on November 4, 2020.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1035.
| 510(k) Number | K203248 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2020 |
| Decision Date | November 23, 2021 |
| Days to Decision | 384 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | CIX - Bromcresol Green Dye-binding, Albumin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1035 |