510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261409Substantially Equivalent

BioTeke® Multi-Drug Urine Test Cup

Bioteke Corporation (Wuxi) Co., Ltd., Wuxi, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

Clearance record

Decision date
Received
(133 days to decision)
Product code
NFT Test, Amphetamine, Over The Counter
Regulation
21 CFR 862.3100
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Bioteke Corporation (Wuxi) Co., Ltd. # 90, Huiming Rd.,Huishan,Wuxi City,Jiangsu,214000,China, Wuxi, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NFT

Trailing 12 months
6 clearances under product code NFT in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NFT, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20261
August 20260
September 20261
October 20260