TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323— 510(k) K003064

Name: FDA 510(k) clearance K003064
Creator: U.S. Food and Drug Administration
Published: 2001-05-01

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K003064 for TINA-QUANT SOLUBLE TRANSFERRIN RECEPTOR TEST SYSTEM, HITACHI CATALOG # 2148315; INTEGRA CATALOG # 2148323, Substantially Equivalent on 2001-05-01. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DDG
Device class: Class 2
Regulation: 21 CFR 866.5880
Advisory panel: Immunology
Date received: 2000-10-02
Decision date: 2001-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K003064

K-number listed on FDA's recall record

Z-0108-2020 — cobas c 311; cobas c 501, 502,and COBAS INTEGRA 400 plus Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 20763454122Class II·Terminated·Roche Diagnostics Operations, Inc.·20190828
Z-0109-2020 — cobas c 701 and 702 Analyzer/Module-RF interference claims for the sTfR assay Catalog Number: 05950821190Class II·Terminated·Roche Diagnostics Operations, Inc.·20190828

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K003064.

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