TQ HBA1C GEN3— 510(k) K102914

Substantially Equivalent

Roche

FDA 510(k) clearance K102914 for TQ HBA1C GEN3, Substantially Equivalent on 2011-01-20. Applicant: Roche.

Clearance details

Applicant: Roche
Product code: Code LCP
Advisory panel: Hematology
Date received: 2010-10-01
Decision date: 2011-01-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

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