K241176 is an FDA 510(k) clearance for the Alere NT-proBNP for Alinity i Reagent Kit. This device is classified as a Test, Natriuretic Peptide (Class II - Special Controls, product code NBC).
Submitted by Axis-Shield Diagnostics, Ltd. (Dundee, GB). The FDA issued a Cleared decision on January 16, 2025, 262 days after receiving the submission on April 29, 2024.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1117.
| 510(k) Number | K241176 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2024 |
| Decision Date | January 16, 2025 |
| Days to Decision | 262 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NBC — Test, Natriuretic Peptide |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1117 |