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

Name: FDA 510(k) clearance K072714
Creator: U.S. Food and Drug Administration
Published: 2008-04-18

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.. 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: 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 ↗

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Recalls naming K072714

K-number listed on FDA's recall record

Z-0395-2017 — Tina-Quant Hemoglobin A1c Gen. 2 Hemoglobin A1c test Catalog number 04528123190 / 05401640190Class II·Terminated·Roche Diagnostics Operations, Inc.·20161004

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072714.

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