510(k) K232164

Device
Access NT-proBNP
Applicant
Beckman Coulter, Inc.
510(k) number
K232164
Product code
NBC
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-12
Date received
2023-07-21
Regulation
862.1117
Classification name
Test, Natriuretic Peptide
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Rachel Clark
Address
1000 Lake Hazeltine Dr. Chaska MN US 55331 55331

FDA Registration Numbers

Source Documents

510(k) summary PDF

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