Elecsys proBNP II, Elecsys proBNP II STAT— 510(k) K223637

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K223637 for Elecsys proBNP II, Elecsys proBNP II STAT, Substantially Equivalent on 2023-07-21. Applicant: Roche Diagnostics.

Clearance details

Applicant
Roche Diagnostics
Product code
Code NBC
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Indianapolis, IN, US
Download summary PDFView on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.