Elecsys BRAHMS PCT— 510(k) K192815

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K192815 for Elecsys BRAHMS PCT, Substantially Equivalent on 2020-03-09. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code PRI
Advisory panel: Microbiology
Date received: 2019-10-01
Decision date: 2020-03-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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