TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM— 510(k) K072714

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K072714 for TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM, Substantially Equivalent on 2008-04-18. Applicant: Roche Diagnostics Corp..

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code LCP
Advisory panel: Hematology
Date received: 2007-09-25
Decision date: 2008-04-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.