510(k) clearances

Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard

Co-Innovation Biotech Co., Ltd. · Clinical Toxicology

K241100Substantially EquivalentTraditionalNGL
Open FDA's page for this record
Third party flag
N
City
Guangzhou
Advisory committee description
Clinical Toxicology
Address 1
#9 Baihe 3 St., Economic And Technological Development
Address 2
East Zone
Statement or summary
Summary
Product code
NGL
Zip code
510530
Applicant
Co-Innovation Biotech Co., Ltd.
Decision date
2024-05-22
Decision code
SESE
Country code
CN
Device name
Rapid Urine Fentanyl (FYL) Test Strip; Rapid Urine Fentanyl (FYL) Test Dipcard
Advisory committee
TX
Contact
Hong Feng
K number
K241100
Date received
2024-04-22
Review advisory committee
TX
Postal code
510530
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.