ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS— 510(k) K013152

Name: FDA 510(k) clearance K013152
Creator: U.S. Food and Drug Administration
Published: 2001-11-09

Substantially Equivalent

Elan Holdings, Inc.

FDA 510(k) clearance K013152 for ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS, Substantially Equivalent on 2001-11-09. Applicant: Elan Holdings, Inc.. Device class: 1.

Clearance details

Applicant: Elan Holdings, Inc.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 2001-09-20
Decision date: 2001-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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