LEAP RHEUMATOID FACTOR TEST KIT— 510(k) K831941

Name: FDA 510(k) clearance K831941
Creator: U.S. Food and Drug Administration
Published: 1983-07-18

Substantially Equivalent

Cooper Diagnostics, Inc.

FDA 510(k) clearance K831941 for LEAP RHEUMATOID FACTOR TEST KIT, Substantially Equivalent on 1983-07-18. Applicant: Cooper Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Cooper Diagnostics, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1983-06-16
Decision date: 1983-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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