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510(k) K210901

Elecsys Vitamin D total III by Roche Diagnostics — Product Code MRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 2021
Date Received
March 26, 2021
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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