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510(k) K040927

LINICAL PROTEIN 1 CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU ANALYZERS by Cliniqa Corporation — Product Code JJX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 2004
Date Received
April 9, 2004
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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