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510(k) K023410

VALIDATE CHEM 10 CALIBRATION VERIFICATION TEST SET, MODEL 110 by Maine Standards Co. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 2003
Date Received
October 10, 2002
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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