VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM— 510(k) K022800

Name: FDA 510(k) clearance K022800
Creator: U.S. Food and Drug Administration
Published: 2002-11-25

Substantially Equivalent

Hyperion, Inc.

FDA 510(k) clearance K022800 for VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM, Substantially Equivalent on 2002-11-25. Applicant: Hyperion, Inc.. Device class: 2.

Clearance details

Applicant: Hyperion, Inc.
Product code: Code DHN
Device class: Class 2
Regulation: 21 CFR 866.5100
Advisory panel: Immunology
Date received: 2002-08-23
Decision date: 2002-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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