OMNI C ANALYZER— 510(k) K013373

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K013373 for OMNI C ANALYZER, Substantially Equivalent on 2001-11-02. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code CEM
Advisory panel: Clinical Chemistry
Date received: 2001-10-11
Decision date: 2001-11-02
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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