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510(k) K072270

DIAZYME CYSTATIN C: ASSAY KIT (DZ133A-K), CALIBRATOR (DZ133A-CAL), CONTROLS (DZ133A-CON) by Diazyme Laboratories — Product Code NDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 1, 2008
Date Received
August 15, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Cystatin C
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

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