TINA-QUANT HBA1C GEN.2— 510(k) K110313

Substantially Equivalent

Roche Diagnostics

FDA 510(k) clearance K110313 for TINA-QUANT HBA1C GEN.2, Substantially Equivalent on 2011-12-23. Applicant: Roche Diagnostics. Device class: 2.

Clearance details

Applicant: Roche Diagnostics
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2011-02-02
Decision date: 2011-12-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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