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510(k) K020450

VALIDATE CHEM 8 CALIBRATION VERIFICATION TEST SET; MODEL 108 by Maine Standards Co. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 2002
Date Received
February 11, 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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