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510(k) K012122

VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005 by Maine Standards Co. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 2001
Date Received
July 6, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Single (Specified) Analyte Controls (Assayed And Unassayed)
Device Class
Class I
Regulation Number
862.1660
Review Panel
CH
Submission Type

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