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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 / October 2025 / K252607

510(k) cleared

AllTest Urinary Tract Infection Test

Hangzhou AllTest Biotech Co., Ltd. · Oct 30, 2025 · K252607

FDA cleared the AllTest Urinary Tract Infection Test from Hangzhou AllTest Biotech Co., Ltd. on Oct 30, 2025 under K252607, a traditional 510(k). The device falls under product code JMT, Diazo (Colorimetric), Nitrite (Urinary, Non-Quant), regulated at 21 CFR 862.1510 as a Class 1 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on Aug 18, 2025. The decision came 73 days later, inside the 90 FDA-day goal for a 510(k).

Hangzhou AllTest Biotech Co., Ltd. has one other decision in the tracker over the last 12 months: K260342 (AllTest Strep A Rapid Test).

Questions & Answers

What did FDA clear under K252607?

K252607 is the FDA 510(k) for AllTest Urinary Tract Infection Test, submitted by Hangzhou AllTest Biotech Co., Ltd.. FDA's decision date was Oct 30, 2025, under product code JMT (Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)).

Who makes the AllTest Urinary Tract Infection Test?

Hangzhou AllTest Biotech Co., Ltd., based in Hangzhou, is the applicant of record for K252607.

How long did the K252607 review take?

FDA received the submission on Aug 18, 2025 and issued its decision on Oct 30, 2025, 73 days later.

← All decisions in October 2025

Sources