K072638

Substantially Equivalent

ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801

Applicant: Roche Diagnostics Corp.
Product code: JGQ
Advisory panel: Clinical Chemistry
Date received: 2007-09-18
Decision date: 2007-10-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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