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510(k) K090475

VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402 by Maine Standards Co. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 2009
Date Received
February 24, 2009
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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