FERRITIN GENERATION 2— 510(k) K031650

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K031650 for FERRITIN GENERATION 2, Substantially Equivalent on 2003-07-17. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DBF
Advisory panel: Immunology
Date received: 2003-05-28
Decision date: 2003-07-17
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.