Access BNP II— 510(k) K252169
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K252169 for Access BNP II, Substantially Equivalent on 2026-03-24. Applicant: Beckman Coulter, Inc.. Device class: 2.
Summary
Beckman Coulter's Access BNP II is filed under NBC, natriuretic peptide tests. The record doesn't describe the assay beyond its name and that code name.
Class II, 21 CFR 862.1117. It was a Traditional 510(k), and Clinical Chemistry is both the classification panel and the review panel.
Beckman Coulter filed from Chaska, Minnesota. The decision came 257 calendar days after FDA received it (July 10, 2025 to March 24, 2026).
Clearance details
- Applicant
- Beckman Coulter, Inc.
- Product code
- Product code NBC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1117
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chaska, MN, US
Recent devices under product code NBC
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