TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST— 510(k) K052464

Name: FDA 510(k) clearance K052464
Creator: U.S. Food and Drug Administration
Published: 2005-09-30

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K052464 for TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST, Substantially Equivalent on 2005-09-30. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code LCP
Device class: Class 2
Regulation: 21 CFR 864.7470
Advisory panel: Hematology
Date received: 2005-09-08
Decision date: 2005-09-30
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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