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510(k) K093680

DIAZYME CYSTATIN C ASSAY by Diazyme Laboratories — Product Code NDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 8, 2010
Date Received
November 27, 2009
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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  • K093960 — ST AIA-PACK CYSTATIN C, MODEL 025217 (September 14, 2010)
  • K083906 — ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODEL (March 11, 2009)
  • K081875 — GENTIAN CYSTATIN C IMMUNOASSAY (August 20, 2008)