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510(k) K062501

VALIDATE THYROID CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 901 by Maine Standards Co. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 29, 2006
Date Received
August 25, 2006
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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