BioTeke® Multi-Drug Urine Test Cup
Bioteke Corporation (Wuxi) Co., Ltd. · Clinical Toxicology
Open FDA's page for this record- Third party flag
- N
- City
- Wuxi
- Advisory committee description
- Clinical Toxicology
- Address 1
- # 90, Huiming Rd.,Huishan,Wuxi City,Jiangsu,214000,China
- Address 2
- 4th Floor, D5, #1719,Huishan Ave. Wuxi, Jiangsu, 214174, Chi
- Statement or summary
- Summary
- Product code
- NFT
- Zip code
- 214000
- Applicant
- Bioteke Corporation (Wuxi) Co., Ltd.
- Decision date
- 2026-09-10
- Decision code
- SESE
- Country code
- CN
- Device name
- BioTeke® Multi-Drug Urine Test Cup
- Advisory committee
- TX
- Contact
- Zhitu Zhou
- K number
- K261409
- Date received
- 2026-04-30
- Review advisory committee
- TX
- Postal code
- 214000
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Test, Amphetamine, Over The Counter
- Medical specialty description
- Clinical Toxicology
- Regulation number
- 862.3100
- Device class
- 2
- Registration number
- 3006305917, 3023322455, 3016659819, 3012073813, 1417592, 3043196750, 2087033, 3016837106, 3013077867, 3012725363, 3010852191, 3008517993, 3004635103, 3010220539, 3014301129, 3011522054, 3009238284, 3015821396, 3008741972, 3017060097, 3016447251, 3003917514, 3024463179, 2029372, 3005360469, 3030648160, 3032147516, 3043127647, 3038614708, 3021986677, 3005984081, 3009414546, 3023296261, 2030633, 3031697086, 3038560224, 1649661, 3027519599, 3024753119, 3021186226 +15 more
- FEI number
- 3006305917, 3023322455, 3016659819, 3012073813, 1417592, 3043196750, 3016837106, 3013077867, 1000306617, 3012725363, 3010852191, 3008517993, 3004635103, 3001452245, 3010220539, 3014301129, 3011522054, 3009238284, 3015821396, 3008741972, 3017060097, 3000210620, 3016447251, 3003917514, 3024463179, 3030648160, 3032147516, 3038614708, 3043127647, 3021986677, 3005984081, 3009414546, 3023296261, 3031697086, 3038560224, 3027519599, 3024753119, 3003102569, 3021186226, 3036649420 +15 more