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510(k) K161817

Tina-quant Cystatin C Gen.2 by Roche Diagnostics Operations (Rdo) — Product Code NDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 27, 2016
Date Received
July 1, 2016
Clearance Type
Special
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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Other clearances for product code NDY

  • K242585 — Cystatin C (May 16, 2025)
  • K181082 — ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) (May 25, 2018)
  • K171072 — N Latex Cystatin C; N Protein Standard UY (May 12, 2017)
  • 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)
  • K081875 — GENTIAN CYSTATIN C IMMUNOASSAY (August 20, 2008)