Home / 510(k) Clearances / K171072

510(k) K171072

N Latex Cystatin C; N Protein Standard UY by Siemens Healthcare Diagnostics Products GmbH — Product Code NDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 2017
Date Received
April 10, 2017
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 Siemens Healthcare Diagnostics Products GmbH

  • K240315 — INNOVANCE Anti-Xa (OPPU05); INNOVANCE Apixaban Standards (OPPW05); INNOVANCE Api (October 10, 2024)
  • K233946 — IMMULITE® 2000 BR-MA (March 13, 2024)
  • K233663 — N Antisera to Human Immunoglobulins (IgG, IgA, and IgM) (December 13, 2023)
  • K213510 — IMMULITE/IMMULITE 1000 OM-MA, IMMULITE 2000 OM-MA (September 8, 2023)
  • K220728 — vWF Ag (June 2, 2023)
  • K212559 — CardioPhase® hsCRP (December 16, 2022)
  • DEN200067 — INNOVANCE VWF Ac (September 29, 2022)
  • K212379 — N Latex FLC kappa, N Latex FLC lambda (March 2, 2022)
  • K201496 — N Latex FLC kappa, N Latex FLC lambda (October 29, 2021)
  • K193047 — N Latex FLC kappa, N Latex FLC lambda (July 14, 2021)

Other clearances for product code NDY

  • K242585 — Cystatin C (May 16, 2025)
  • K181082 — ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) (May 25, 2018)
  • 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)
  • K081875 — GENTIAN CYSTATIN C IMMUNOASSAY (August 20, 2008)