K103221

Substantially Equivalent

ELECYS HGH CALSET, ELECSYS HGH CALCHECK 5

Applicant: Roche Diagnostics
Product code: JIT
Advisory panel: Clinical Chemistry
Date received: 2010-11-01
Decision date: 2010-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

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