510(k) K113072— TINA-QUANT ALBUMIN GEN.2

Substantially Equivalent

Roche Diagnostics Operations

Clearance details

Applicant: Roche Diagnostics Operations
Product code: Code DCF
Advisory panel: Immunology
Date received: 2011-10-17
Decision date: 2012-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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