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510(k) K221326

Nova Allegro HbA1c Assay, Nova Allegro Analyzer by Nova Biomedical Corporation — Product Code LCP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 22, 2024
Date Received
May 6, 2022
Clearance Type
Dual Track
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Assay, Glycosylated Hemoglobin
Device Class
Class II
Regulation Number
864.7470
Review Panel
HE
Submission Type

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Other clearances for product code LCP

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  • K192987 — Aina HbA1c Monitoring System 2 (March 26, 2020)
  • K192369 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit (October 29, 2019)
  • K183230 — OneDraw A1C Test System (August 15, 2019)
  • K181915 — PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit (April 12, 2019)
  • K180509 — Quo-Test A1c System (February 16, 2019)
  • K173127 — skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c (September 25, 2018)
  • K170623 — ACE Hemoglobin A1c (HbA1c) Reagent (February 27, 2018)
  • K171650 — Alere Afinion HbA1c and ACR on Afinion 2 analyzer (November 21, 2017)