K140496

Substantially Equivalent

Access Vitamin B12 Assay, Access Ferritin Assay, Access Folate Assay, Access HYPERsensitive hTSH Assay, Power Express Sample Processing System Generic Connection Module and Access Immunoassay System Reagents

Applicant: Beckman Coulter, Inc.
Product code: CDD
Advisory panel: Clinical Chemistry
Date received: 2014-02-27
Decision date: 2014-09-16
Decision: Substantially Equivalent
Clearance type: Special
Location: Brea, CA, US

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