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510(k) K080662

GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR by Genzyme Corporation — Product Code NDY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 15, 2008
Date Received
March 10, 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 Genzyme Corporation

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  • K092633 — OSOM INFLUENZA A&B TEST , MODEL PN190 (September 25, 2009)
  • K063739 — SEPRAMESH, MODEL 5959-1214 (January 17, 2007)
  • K053066 — SEPRAMESH IP BIORESORBABLE COATING/PERMANENT MESH (December 19, 2005)
  • K043035 — SEPRAGEL ENT BIORESORBABLE PACKING/STENT (July 11, 2005)

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)