K040435

Substantially Equivalent

ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2

Applicant: Roche Diagnostics Corp.
Product code: CZP
Advisory panel: Immunology
Date received: 2004-02-19
Decision date: 2004-03-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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