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THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / January 2026 / K252206

510(k) cleared

Nova Allegro UACR Assay, Nova Allegro Analyzer

Nova Biomedical Corporation · Jan 9, 2026 · K252206

FDA cleared the Nova Allegro UACR Assay, Nova Allegro Analyzer from Nova Biomedical Corporation on Jan 9, 2026 under K252206, a dual track 510(k). The device falls under product code CGX, Alkaline Picrate, Colorimetry, Creatinine, regulated at 21 CFR 862.1225 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Jul 14, 2025. The decision came 179 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Nova Biomedical Corporation has one other decision in the tracker over the last 12 months: K251281 (Nova Max Creat eGFR Monitoring System).

Questions & Answers

What did FDA clear under K252206?

K252206 is the FDA 510(k) for Nova Allegro UACR Assay, Nova Allegro Analyzer, submitted by Nova Biomedical Corporation. FDA's decision date was Jan 9, 2026, under product code CGX (Alkaline Picrate, Colorimetry, Creatinine).

Who makes the Nova Allegro UACR Assay, Nova Allegro Analyzer?

Nova Biomedical Corporation, based in Walham, MA, is the applicant of record for K252206.

How long did the K252206 review take?

FDA received the submission on Jul 14, 2025 and issued its decision on Jan 9, 2026, 179 days later.

← All decisions in January 2026

Sources