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510(k) K080384

HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER by The Binding Site, Ltd. — Product Code NDY

K080384 is an FDA 510(k) premarket notification submitted by The Binding Site, Ltd. for the device "HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER". The FDA issued a decision of Substantially Equivalent on June 6, 2008. The device falls under product code NDY (Test, Cystatin C), a Class II device regulated under 21 CFR 862.1225. The Binding Site, Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2008
Date Received
February 13, 2008
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 The Binding Site, Ltd.

  • K231290 — Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free Kit (January 24, 2024)
  • K140105 — HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA (March 18, 2014)
  • K132555 — HEVYLITE HUMAN IGG KAPPA KIT AND HEVYLITE HUMAN IGG LAMBDA KIT (December 20, 2013)
  • K103824 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPA PLUS (February 27, 2012)
  • K100455 — SPAPLUS ANALYZER (September 3, 2010)
  • K090920 — HUMAN IGG SUBCLASS LIQUID REAGENT KITS (FOR USE ON HITACHI 911/ 912/ 917 AND MOD (December 30, 2009)
  • K092450 — HUMAN IGD KIT FOR USE ON SPAPLUS (December 28, 2009)
  • K083289 — HUMAN BETA-2 MICROGLOBULIN KIT (May 6, 2009)
  • K082129 — HUMAN IGM LIQUID REAGENT KIT FOR USE ON THE SPAPLUS ANALYZER (February 10, 2009)
  • K081827 — HUMAN IGA LIQUID REAGENT KIT FOR USE ON SPAPLUS (December 19, 2008)

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)
  • 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)

FDA data resources