ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS— 510(k) K000900

Name: FDA 510(k) clearance K000900
Creator: U.S. Food and Drug Administration
Published: 2000-05-02

Substantially Equivalent

Elan Holdings, Inc.

FDA 510(k) clearance K000900 for ATAC PAK CHOLESTEROL REAGENT AND ATAC CALLIBRATOR KITS, Substantially Equivalent on 2000-05-02. Applicant: Elan Holdings, Inc.. Device class: 1.

Clearance details

Applicant: Elan Holdings, Inc.
Product code: Code CHH
Device class: Class 1
Regulation: 21 CFR 862.1175
Advisory panel: Clinical Chemistry
Date received: 2000-03-21
Decision date: 2000-05-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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