ELECSYS PRECICONTROL UNIVERSAL— 510(k) K090541

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K090541 for ELECSYS PRECICONTROL UNIVERSAL, Substantially Equivalent on 2009-07-02. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code JJY
Advisory panel: Clinical Chemistry
Date received: 2009-03-02
Decision date: 2009-07-02
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.