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510(k) K130157

AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET by Aalto Scientific, Ltd. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 19, 2013
Date Received
January 23, 2013
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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