510(k) K252169

Access BNP II by Beckman Coulter, Inc. — Product Code NBC

K252169 is an FDA 510(k) premarket notification submitted by Beckman Coulter, Inc. for the device "Access BNP II". The FDA issued a decision of Substantially Equivalent on March 24, 2026. The device falls under product code NBC (Test, Natriuretic Peptide), a Class II device regulated under 21 CFR 862.1117. Beckman Coulter, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 2026
Date Received
July 10, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Natriuretic Peptide
Device Class
Class II
Regulation Number
862.1117
Review Panel
CH
Submission Type