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510(k) K113524

VALIDATE VIT D CALIBRATION VERIFICATION/ LINEARITY TEST KIT by Maine Standards Co. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2012
Date Received
November 29, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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