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510(k) K110880

VALIDATE (R) GC3 CALIBRATION VERIFICATION / LINEARITY TEST KIT by Maine Standards Company, LLC — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 5, 2011
Date Received
March 30, 2011
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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