510(k) clearances

Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro

Guangzhou Decheng Biotechnology Co., Ltd. · Clinical Toxicology

K250067Substantially EquivalentTraditionalNGL
Open FDA's page for this record
Third party flag
N
City
Guangzhou
Advisory committee description
Clinical Toxicology
Address 1
Floor 3/4/5/7, Bldg. A1, #12, Nanyun 1st Rd.
Address 2
Science City, Huangpu District
Statement or summary
Summary
Product code
NGL
Zip code
510663
Applicant
Guangzhou Decheng Biotechnology Co., Ltd.
Decision date
2025-02-20
Decision code
SESE
Country code
CN
Device name
Dochek® Multi-Drug Urine Test Cup; Dochek® Multi-Drug Urine Test Cup Pro
Advisory committee
TX
Contact
Mango Huang
K number
K250067
Date received
2025-01-10
Review advisory committee
TX
Postal code
510663
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Test, Opiates, Over The Counter
Medical specialty description
Clinical Toxicology
Regulation number
862.3650
Device class
2
Registration number
3008054239, 2087033, 3008517993, 1417592, 3005360469, 3043127647, 2060833, 3031823359, 3021986677, 3009212837, 3013077867, 3006305917, 3006048451, 3030648160, 3016447251, 3009414546, 3017060097, 3004635103, 3031697086, 3030413233, 3016609999, 3017904598, 3024753119, 3025041446, 3038560224, 1910144, 3005641941, 3036649420, 3013223546, 1649661, 3038614708, 3027519599, 3032147516, 3005984081, 3043196750, 3010220539, 3010852191, 3009238284, 3030897502, 3014223276 +22 more
FEI number
3008054239, 3008517993, 1417592, 3043127647, 3003102569, 3031823359, 3021986677, 3009212837, 3013077867, 3006305917, 3006048451, 3030648160, 1000306617, 3016447251, 3009414546, 3017060097, 3004635103, 3031697086, 3030413233, 3016609999, 3017904598, 3024753119, 3025041446, 3038560224, 1910144, 3005641941, 3036649420, 3013223546, 3001452245, 3038614708, 3027519599, 3032147516, 3005984081, 3000210620, 3043196750, 3010220539, 3010852191, 3009238284, 3030897502, 3014223276 +22 more
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.