MODIFICATION TO VIGIL LIPID CONTROL— 510(k) K020521

Name: FDA 510(k) clearance K020521
Creator: U.S. Food and Drug Administration
Published: 2002-03-01

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K020521 for MODIFICATION TO VIGIL LIPID CONTROL, Substantially Equivalent on 2002-03-01. Applicant: Beckman Coulter, Inc.. Device class: 1.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JJY
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2002-02-19
Decision date: 2002-03-01
Decision: Substantially Equivalent
Clearance type: Special
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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