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510(k) K071388

GENTIAN CYSTATIN C IMMUNOASSAY by Gentian AS — Product Code NDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 6, 2007
Date Received
May 18, 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

Other clearances by Gentian AS

  • K081875 — GENTIAN CYSTATIN C IMMUNOASSAY (August 20, 2008)

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  • K171072 — N Latex Cystatin C; N Protein Standard UY (May 12, 2017)
  • K161817 — Tina-quant Cystatin C Gen.2 (July 27, 2016)
  • K141143 — COBAS C TINA-QUANT CYSTATIN C GEN.2 ASSAY, C.F.A.S. CYSTATIN C CALIBRATOR, CYSTA (July 17, 2014)
  • K111664 — DIAZYME CYSTATIN C POC TEST KIT (March 30, 2012)
  • K093137 — K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROL (September 28, 2010)
  • K093960 — ST AIA-PACK CYSTATIN C, MODEL 025217 (September 14, 2010)
  • K093680 — DIAZYME CYSTATIN C ASSAY (April 8, 2010)
  • K083906 — ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODEL (March 11, 2009)