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510(k) K142964

VALIDATE Anemia Calibration Verification/ Linearity Test Kit by Maine Standards Company, LLC — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2015
Date Received
October 14, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Multi-Analyte Controls, All Kinds (Assayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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