510(k) clearances

EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II

Nantong Egens Biotechnology Co., Ltd. · Clinical Chemistry

K232864Substantially EquivalentTraditionalLCX
Open FDA's page for this record
Third party flag
N
City
Nantong
Advisory committee description
Clinical Chemistry
Address 1
No 1692 Xinghu Ave.
Address 2
Nantong Economy & Technology Development Zone
Statement or summary
Summary
Product code
LCX
Zip code
226010
Applicant
Nantong Egens Biotechnology Co., Ltd.
Decision date
2024-01-26
Decision code
SESE
Country code
CN
Device name
EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II
Advisory committee
CH
Contact
Ouweijun .
K number
K232864
Date received
2023-09-15
Review advisory committee
CH
Postal code
226010
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Kit, Test, Pregnancy, Hcg, Over The Counter
Medical specialty description
Clinical Chemistry
Regulation number
862.1155
Device class
2
Registration number
3008054239, 8043323, 3007838093, 3043127647, 3009526336, 3013332582, 3010879605, 3016447251, 3017904598, 3024753119, 3021562175, 2025099, 2531491, 3006635320, 3010220539, 3003741676, 3005569927, 3003917514, 3008808560, 3027500452, 3018786392, 3010131137, 1417592, 3013501873, 3005360469, 3006479639, 3006305917, 3007154442, 3030648160, 3028107593, 3009414546, 3004635103, 3007583565, 3038560224, 3031664550, 3008852306, 3033507883, 3030531253, 3014171027, 1649661 +85 more
FEI number
3008054239, 3007838093, 3043127647, 3009526336, 3013332582, 3010879605, 3003102569, 3006078362, 3016447251, 3017904598, 3024753119, 3021562175, 3006635320, 3010220539, 3003741676, 3005569927, 3003917514, 3003075526, 3027500452, 3018786392, 1000118544, 3010131137, 3007981058, 1417592, 3013501873, 3006479639, 3006305917, 3007154442, 3030648160, 3028107593, 3009414546, 3004635103, 3007583565, 3038560224, 3031664550, 3008852306, 3033507883, 3030531253, 3001452245, 3003516723 +85 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.