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510(k) K101427

AUDIT MICROCV HS-CRP LINEARITY SET by Aalto Scientific, Ltd. — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2010
Date Received
May 21, 2010
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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