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510(k) K143571

Audit MicroControls Linearity LQ Cystatin-C by Aalto Scientific, Ltd. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 23, 2015
Date Received
December 17, 2014
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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