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510(k) K040535

LINICAL ENZYME CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON SYSTEMS by Cliniqa Corporation — Product Code JJY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 2004
Date Received
March 2, 2004
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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