Access NT-proBNP— 510(k) K262109
Substantially EquivalentBeckman Coulter, Inc.
FDA 510(k) clearance K262109 for Access NT-proBNP, Substantially Equivalent on 2026-09-21. Applicant: Beckman Coulter, Inc.. Device class: 2.
Summary
Access NT-proBNP is a Beckman Coulter, Inc. submission under product code NBC (Test, Natriuretic Peptide). The record doesn't give anything about the test beyond its name and code.
Class II, 21 CFR 862.1117. Clinical Chemistry is both the classification panel and the review panel, and it came in as a Traditional 510(k). The decision was Substantially Equivalent.
Beckman Coulter filed from Chaska, Minnesota. FDA received it on June 23, 2026 and decided it on September 21, 2026, 90 calendar days later.
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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