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— 510(k) K140496

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K140496 for 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, Substantially Equivalent on 2014-09-16. Applicant: Beckman Coulter, Inc..

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: 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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