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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 / September 2025 / K252554

510(k) cleared

Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup

Vivachek Biotech (Hangzhou) Co., Ltd. · Sep 12, 2025 · K252554

FDA cleared the Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup from Vivachek Biotech (Hangzhou) Co., Ltd. on Sep 12, 2025 under K252554, a traditional 510(k). The device falls under product code NFT, Test, Amphetamine, Over The Counter, regulated at 21 CFR 862.3100 as a Class 2 device. The review panel was Clinical Toxicology.

FDA logged the submission as received on Aug 13, 2025. The decision came 30 days later, inside the 90 FDA-day goal for a 510(k).

Vivachek Biotech (Hangzhou) Co., Ltd. has one other decision in the tracker over the last 12 months: K261280 (BioSieve Multi-Drug Urine Test Panel;BioSieve Multi-Drug Urine Home Test Panel).

Questions & Answers

What did FDA clear under K252554?

K252554 is the FDA 510(k) for Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup, submitted by Vivachek Biotech (Hangzhou) Co., Ltd.. FDA's decision date was Sep 12, 2025, under product code NFT (Test, Amphetamine, Over The Counter).

Who makes the Wisdiag Multi-Drug Urine Test Cup; Wisdiag Multi-Drug Urine Home Test Cup?

Vivachek Biotech (Hangzhou) Co., Ltd., based in Hangzhou, is the applicant of record for K252554.

How long did the K252554 review take?

FDA received the submission on Aug 13, 2025 and issued its decision on Sep 12, 2025, 30 days later.

← All decisions in September 2025

Sources