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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 / April 2026 / K260342

510(k) cleared

AllTest Strep A Rapid Test

Hangzhou AllTest Biotech Co., Ltd. · Apr 30, 2026 · K260342

FDA cleared the AllTest Strep A Rapid Test from Hangzhou AllTest Biotech Co., Ltd. on Apr 30, 2026 under K260342, a traditional 510(k). The device falls under product code GTY, Antigens, All Groups, Streptococcus Spp., regulated at 21 CFR 866.3740 as a Class 1 device. The review panel was Microbiology.

FDA logged the submission as received on Feb 2, 2026. The decision came 87 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: K252607 (AllTest Urinary Tract Infection Test).

Questions & Answers

What did FDA clear under K260342?

K260342 is the FDA 510(k) for AllTest Strep A Rapid Test, submitted by Hangzhou AllTest Biotech Co., Ltd.. FDA's decision date was Apr 30, 2026, under product code GTY (Antigens, All Groups, Streptococcus Spp.).

Who makes the AllTest Strep A Rapid Test?

Hangzhou AllTest Biotech Co., Ltd., based in Hangzhou, is the applicant of record for K260342.

How long did the K260342 review take?

FDA received the submission on Feb 2, 2026 and issued its decision on Apr 30, 2026, 87 days later.

← All decisions in April 2026

Sources