510(k) K062239— GLUCOSE HK NEW FORMULATION TEST SYSTEM

Substantially Equivalent

Roche Diagnostics Corp.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code CFR
Advisory panel: Clinical Chemistry
Date received: 2006-08-02
Decision date: 2006-09-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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