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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K261409

510(k) cleared

BioTeke® Multi-Drug Urine Test Cup

Bioteke Corporation (Wuxi) Co., Ltd. · Sep 10, 2026 · K261409

FDA cleared the BioTeke® Multi-Drug Urine Test Cup from Bioteke Corporation (Wuxi) Co., Ltd. on Sep 10, 2026 under K261409, 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 Apr 30, 2026. The decision came 133 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 Bioteke Corporation (Wuxi) Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261409?

K261409 is the FDA 510(k) for BioTeke® Multi-Drug Urine Test Cup, submitted by Bioteke Corporation (Wuxi) Co., Ltd.. FDA's decision date was Sep 10, 2026, under product code NFT (Test, Amphetamine, Over The Counter).

Who makes the BioTeke® Multi-Drug Urine Test Cup?

Bioteke Corporation (Wuxi) Co., Ltd., based in Wuxi, is the applicant of record for K261409.

How long did the K261409 review take?

FDA received the submission on Apr 30, 2026 and issued its decision on Sep 10, 2026, 133 days later.

← All decisions in September 2026