K033491

Substantially Equivalent

ROCHE DIAGNOSTICS CARDIAC D-DIMER RAPID ASSAY; ROCHE DIAGNOSTICS CARDIAC D-DIMER CONTROLS

Applicant: Roche Diagnostics Corp.
Product code: DAP
Advisory panel: Hematology
Date received: 2003-11-04
Decision date: 2004-09-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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