COBAS U411 TEST SYSTEM— 510(k) K093555

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K093555 for COBAS U411 TEST SYSTEM, Substantially Equivalent on 2010-04-02. Applicant: Roche Diagnostics.

Clearance details

Applicant: Roche Diagnostics
Product code: Code KQO
Advisory panel: Clinical Chemistry
Date received: 2009-11-17
Decision date: 2010-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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