ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM— 510(k) K033802

Name: FDA 510(k) clearance K033802
Creator: U.S. Food and Drug Administration
Published: 2004-02-27

Substantially Equivalent

Zeus Scientific, Inc.

FDA 510(k) clearance K033802 for ATHENA MULTI-LITE RHEUMATOID FACTOR IGM TEST SYSTEM, Substantially Equivalent on 2004-02-27. Applicant: Zeus Scientific, Inc.. Device class: 2.

Clearance details

Applicant: Zeus Scientific, Inc.
Product code: Code DHR
Device class: Class 2
Regulation: 21 CFR 866.5775
Advisory panel: Immunology
Date received: 2003-12-08
Decision date: 2004-02-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branchburg, NJ, US

Download summary PDF View on FDA.gov ↗

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