ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2— 510(k) K040431

Name: FDA 510(k) clearance K040431
Creator: U.S. Food and Drug Administration
Published: 2004-03-10

Substantially Equivalent

Roche Diagnostics Corp.

FDA 510(k) clearance K040431 for ROCHE DIAGNOSTICS TINA-QUANT IGM GEN.2, Substantially Equivalent on 2004-03-10. Applicant: Roche Diagnostics Corp.. Device class: 2.

Clearance details

Applicant: Roche Diagnostics Corp.
Product code: Code DAO
Device class: Class 2
Regulation: 21 CFR 866.5550
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 K040431

K-number listed on FDA's recall record

Z-1147-2019 — Tina-quant IgM Gen.2, Catalog Nos. 03507190190, 05220726190, 03507041190, 03507149190 Product Usage: Immunoturbidimetric assay for the quantitative in vitro determination of IgM in human serum and plasma on automated clinical chemistry analyzers analyzers.Class II·Terminated·Roche Diagnostics Corporation·20181217

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040431.

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