Cleared Dual Track

Nova Allegro UACR Assay, Nova Allegro Analyzer

K221813 · Nova Biomedical Corporation · Chemistry
Nov 2024
Decision
881d
Days
Class 2
Risk

About This 510(k) Submission

K221813 is an FDA 510(k) clearance for the Nova Allegro UACR Assay, Nova Allegro Analyzer, a Alkaline Picrate, Colorimetry, Creatinine (Class II — Special Controls, product code CGX), submitted by Nova Biomedical Corporation (Walham, US). The FDA issued a Cleared decision on November 19, 2024, 881 days after receiving the submission on June 22, 2022. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K221813 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2022
Decision Date November 19, 2024
Days to Decision 881 days
Submission Type Dual Track
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CGX — Alkaline Picrate, Colorimetry, Creatinine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1225

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