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510(k) K221813

Nova Allegro UACR Assay, Nova Allegro Analyzer by Nova Biomedical Corporation — Product Code CGX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2024
Date Received
June 22, 2022
Clearance Type
Dual Track
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alkaline Picrate, Colorimetry, Creatinine
Device Class
Class II
Regulation Number
862.1225
Review Panel
CH
Submission Type

Other clearances by Nova Biomedical Corporation

  • K251281 — Nova Max Creat eGFR Monitoring System (January 21, 2026)
  • K252206 — Nova Allegro UACR Assay, Nova Allegro Analyzer (January 9, 2026)
  • K221326 — Nova Allegro HbA1c Assay, Nova Allegro Analyzer (November 22, 2024)
  • K232075 — StatStrip Glucose Hospital Meter System (February 23, 2024)
  • K221900 — Stat Profile Prime Plus Analyzer System (September 29, 2023)
  • K203549 — Nova Primary Glucose Analyzer System (October 18, 2022)
  • K200403 — Stat Profile Prime Plus Analyzer System (April 14, 2020)
  • K200204 — Stat Profile Prime Plus Analyzer System (April 6, 2020)
  • K200349 — Stat Profile Prime Plus Analyzer System (March 13, 2020)
  • K193246 — Stat Profile Prime Plus Analyzer System (January 24, 2020)

Other clearances for product code CGX

  • K252206 — Nova Allegro UACR Assay, Nova Allegro Analyzer (January 9, 2026)
  • K251058 — Tru Kidney Health Test Panel; Tru Analyzer (November 26, 2025)
  • K242685 — Atellica® CH Creatinine_3 (Crea3) (December 4, 2024)
  • K210452 — Creatinine2 (March 22, 2022)
  • K161494 — Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL) (November 15, 2016)
  • K132638 — DIMENSION CREATININE (CRE2) FLEX REAGENT CARTRIDGE (January 27, 2014)
  • K133728 — DIMENSION VISTA CREATININE (CRE2) FLEX REAGENT CARTRIDGE (January 24, 2014)
  • K123586 — EASYRA CREATININE REAGENT (May 15, 2013)
  • K110530 — ABX PENTRA CREATININE 120 CP; ABX PENTRA MULTICAL; ABX PENTRA N CONTROL; ABX PE (April 30, 2012)
  • K083809 — CREATININE (April 7, 2009)