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FDA 510(k)

BioTeke® Multi-Drug Urine Test Cup

K-Number: K261409 · 2026-09-10

Decision Date2026-09-10
Product CodeNFT
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

BioTeke® Multi-Drug Urine Test Cup is the device name listed in this FDA 510(k) record. The listed applicant is Bioteke Corporation (Wuxi) Co., Ltd.. It received FDA 510(k) clearance on 2026-09-10 under 510(k) number K261409. The device is classified under product code NFT. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BioTeke® Multi-Drug Urine Test Cup?

BioTeke® Multi-Drug Urine Test Cup is a medical device that received FDA 510(k) clearance on 2026-09-10. The listed applicant is Bioteke Corporation (Wuxi) Co., Ltd.. The 510(k) number is K261409.

When did BioTeke® Multi-Drug Urine Test Cup receive FDA 510(k) clearance?

BioTeke® Multi-Drug Urine Test Cup received FDA 510(k) clearance on 2026-09-10, under 510(k) number K261409.

Who is the listed applicant for BioTeke® Multi-Drug Urine Test Cup?

The FDA 510(k) record lists Bioteke Corporation (Wuxi) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BioTeke® Multi-Drug Urine Test Cup?

The FDA product code for BioTeke® Multi-Drug Urine Test Cup is NFT.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Other records listing Bioteke Corporation (Wuxi) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: NFT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.