K142362

Substantially Equivalent

Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno.

Applicant: Beckman Coulter, Inc.
Product code: MRG
Advisory panel: Clinical Chemistry
Date received: 2014-08-25
Decision date: 2014-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

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