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510(k) K100718

AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5 by Aalto Scientific, Ltd. — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2010
Date Received
March 12, 2010
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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