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510(k) K033879

VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 by Maine Standards Co. — Product Code DKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 2004
Date Received
December 15, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrators, Drug Mixture
Device Class
Class II
Regulation Number
862.3200
Review Panel
TX
Submission Type

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