RHEUMATOID FACTOR LATEX SLIDE TEST KIT— 510(k) K961169

Name: FDA 510(k) clearance K961169
Creator: U.S. Food and Drug Administration
Published: 1996-06-26

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K961169 for RHEUMATOID FACTOR LATEX SLIDE TEST KIT, Substantially Equivalent on 1996-06-26. Applicant: Randox Laboratories, Ltd.. Device class: 2.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1996-03-25
Decision date: 1996-06-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, IE

Download summary PDF View on FDA.gov ↗

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