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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 / K252283

510(k) cleared

Nano-Check Influenza A+B Test

Nano-Ditech Corporation · Jan 15, 2026 · K252283

FDA cleared the Nano-Check Influenza A+B Test from Nano-Ditech Corporation on Jan 15, 2026 under K252283, a dual track 510(k). The device falls under product code PSZ, Devices Detecting Influenza A, B, And C Virus Antigens, regulated at 21 CFR 866.3328 as a Class 2 device. The review panel was Microbiology.

FDA logged the submission as received on Jul 22, 2025. The decision came 177 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Nano-Ditech Corporation in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K252283?

K252283 is the FDA 510(k) for Nano-Check Influenza A+B Test, submitted by Nano-Ditech Corporation. FDA's decision date was Jan 15, 2026, under product code PSZ (Devices Detecting Influenza A, B, And C Virus Antigens).

Who makes the Nano-Check Influenza A+B Test?

Nano-Ditech Corporation, based in Cranbury, NJ, is the applicant of record for K252283.

How long did the K252283 review take?

FDA received the submission on Jul 22, 2025 and issued its decision on Jan 15, 2026, 177 days later.

← All decisions in January 2026