RHEUMATOID FACTOR LATEX-ENHANCED IMMUNOTURBIDIMETRIC TEST KIT— 510(k) K972220

Clearance details

Applicant

Randox Laboratories, Ltd.

Product code

Code DHR

Device class

Class 2

Regulation

21 CFR 866.5775

Advisory panel

Immunology

Date received

1997-06-12

Decision date

1997-09-09

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Crumlin, Co. Antrim, IE

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• Z-0282-2020 — Rheumatoid Factor Standard (RF CAL) Catalogue Number: RF2301 GTIN: 05055273205039 Product Usage: The Randox Rheumatoid Factor Latex-Enhanced Immunorutbidimetric Test Kit is an in vitro diagnostic reagent for the quantitative determination of rheumatoid factors (RF) in human serum. This test kit may be used to facilitate the detection and diagnosis of Rheumatoid Arthritis. RF have also been observed in the serum of patients with systemic lupus eruthematosus, hepatitis. Liver cirrhosis and syphilis. However, in these conditions the RF titre is much lower than in rheumatoid arthritis. This test kit must be used by suitably qualified personnel under appropriate laboratory conditions. RF calibrator and RF positive control are for use in the calibration and quality control of RF latex-enhanced immunoturbidimetric assays.Class II·Terminated·Randox Laboratories Ltd.·20190809

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K972220.