Cleared Dual Track

Nova Allegro UACR Assay, Nova Allegro Analyzer

K252206 · Nova Biomedical Corporation · Chemistry
Jan 2026
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K252206 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 January 9, 2026, 179 days after receiving the submission on July 14, 2025. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1225.

Submission Details

510(k) Number K252206 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2025
Decision Date January 09, 2026
Days to Decision 179 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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