DeviceClearance

ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM— 510(k) K101456

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K101456 for ROCHE DIAGNOSTICS CALIBRATOR FOR AUTOMATED SYSTEMS, ROCHE DIAGNOSTICS CALIBRATOR CALIBRATOR FOR AUTOMATED SYSTEM, Substantially Equivalent on 2010-09-08. Applicant: Roche Diagnostics.

Clearance details

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

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