ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2— 510(k) K040435

Name: FDA 510(k) clearance K040435
Creator: U.S. Food and Drug Administration
Published: 2004-03-10

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K040435 for ROCHE DIAGNOSTICS TINA-QUANT IGA GEN.2, Substantially Equivalent on 2004-03-10. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code CZP
Device class: Class 2
Regulation: 21 CFR 866.5510
Advisory panel: Immunology
Date received: 2004-02-19
Decision date: 2004-03-10
Decision: Substantially Equivalent
Clearance type: Special
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K040435

K-number listed on FDA's recall record

Z-1979-2019 — The Tina-quant lgA Gen.2 is an immunoturbidimetric assay. Anti-lgA antibodies react with antigen in the sample to form an antigen/antibody complex which is measured turbidimetrically.Class II·Terminated·Roche Diagnostics Corporation·20190603

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040435.

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