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510(k) K111664

DIAZYME CYSTATIN C POC TEST KIT by Diazyme Laboratories — Product Code NDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2012
Date Received
June 14, 2011
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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  • K083906 — ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODEL (March 11, 2009)
  • K081875 — GENTIAN CYSTATIN C IMMUNOASSAY (August 20, 2008)