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510(k) K142373

Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst by Beckman Coulter, Inc. — Product Code MRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 22, 2014
Date Received
August 25, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Vitamin D
Device Class
Class II
Regulation Number
862.1825
Review Panel
CH
Submission Type

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