Class Class II
Shinetell Digital Pregnancy Test (K241978)
Description
Shinetell Digital Pregnancy Test by Hangzhou AllTest Biotech Co., Ltd., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK241978
Clearance Date2024-08-13
Clearance TypeTraditional
Product CodeLCX
Regulation Number862.1155
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K241978
A 510(k) clearance is granted by showing substantial equivalence to an earlier legally marketed device, called the predicate. This lineage is named in the 510(k) summary document and is not published by the FDA as a connected dataset. Shinetell Digital Pregnancy Test (K241978) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K222305 | MissLan™ Digital Pregnancy Rapid Test | Guangzhou Decheng Biotechnology Co.... | 2022 |
Trace the full predicate network for K241978
A link appears here only where the predicate could be read from a published 510(k) summary. Where no summary exists or a reference cannot be resolved to a K number, no link is drawn, so a gap means unknown rather than none.