K051890

Substantially Equivalent

ROCHE DIAGNOSTICS COBAS ELECSYS ANTI-TPO

Applicant: Roche Diagnostics Corp.
Product code: JZO
Advisory panel: Immunology
Date received: 2005-07-12
Decision date: 2005-08-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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