510(k) clearances

AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup

Hangzhou AllTest Biotech Co., Ltd. · Clinical Toxicology

K244043Substantially EquivalentTraditionalNFT
Open FDA's page for this record
Third party flag
N
City
Hangzhou
Advisory committee description
Clinical Toxicology
Address 1
#550 Yinhai St.
Statement or summary
Summary
Product code
NFT
Zip code
310018
Applicant
Hangzhou AllTest Biotech Co., Ltd.
Decision date
2025-02-27
Decision code
SESE
Country code
CN
Device name
AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test Cup
Advisory committee
TX
Contact
Rosa Wu
K number
K244043
Date received
2024-12-30
Review advisory committee
TX
Postal code
310018
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
2087033, 3008517993, 1417592, 3005360469, 3043127647, 2060833, 3021986677, 3009212837, 3013077867, 3006305917, 3006048451, 3030648160, 3016447251, 3009414546, 3017060097, 3004635103, 3031697086, 3030413233, 3017904598, 3024753119, 3025041446, 3038560224, 1910144, 3036649420, 3013223546, 1649661, 3038614708, 3027519599, 3032147516, 3005984081, 3043196750, 3010220539, 3010852191, 3009238284, 3014223276, 3012725363, 3023296261, 3007606081, 3024463179, 3016659819 +15 more
FEI number
3008517993, 1417592, 3043127647, 3003102569, 3021986677, 3009212837, 3013077867, 3006305917, 3006048451, 3030648160, 1000306617, 3016447251, 3009414546, 3017060097, 3004635103, 3031697086, 3030413233, 3017904598, 3024753119, 3025041446, 3038560224, 3001451797, 1910144, 3036649420, 3013223546, 3001452245, 3038614708, 3027519599, 3032147516, 3005984081, 3000210620, 3043196750, 3010220539, 3010852191, 3009238284, 3014223276, 3012725363, 3023296261, 3007606081, 3024463179 +15 more
Wholesale access for licensed clinicians.

Free to join: your NPI is checked against the federal registry at signup, then wholesale pricing and the professional shelves open.

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.