K090939

Substantially Equivalent

ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190

Applicant: Roche Diagnostics
Product code: DKB
Advisory panel: Clinical Toxicology
Date received: 2009-04-03
Decision date: 2009-06-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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