IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR— 510(k) K955797

Name: FDA 510(k) clearance K955797
Creator: U.S. Food and Drug Administration
Published: 1996-04-05

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K955797 for IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR, Substantially Equivalent on 1996-04-05. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code DFT
Device class: Class 2
Regulation: 21 CFR 866.5550
Advisory panel: Immunology
Date received: 1995-12-22
Decision date: 1996-04-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, IE

Download summary PDF View on FDA.gov ↗

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Recalls naming K955797

K-number listed on FDA's recall record

Z-0363-2023 — IgM Immunoturbidimetric Assay-In vitro determination of IgA and IgM in serum and plasma Catalog Number: IM3834Class II·Terminated·Randox Laboratories Ltd.·20221101

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K955797.

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