K013152

Substantially Equivalent

ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS

Applicant: Elan Holdings, Inc.
Product code: LBS
Advisory panel: Clinical Chemistry
Date received: 2001-09-20
Decision date: 2001-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

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