TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL— 510(k) K922725

Name: FDA 510(k) clearance K922725
Creator: U.S. Food and Drug Administration
Published: 1992-10-05

Substantially Equivalent

Simplicity Diagnostics, Inc.

FDA 510(k) clearance K922725 for TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL, Substantially Equivalent on 1992-10-05. Applicant: Simplicity Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Simplicity Diagnostics, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 1992-06-05
Decision date: 1992-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hatboro, PA, US

Download summary PDF View on FDA.gov ↗

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