Shinetell PlusTM Digital Early Pregnancy Test (K251053)
Description
Shinetell PlusTM Digital Early Pregnancy Test by Hangzhou AllTest Biotech Co., Ltd., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K251053
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 PlusTM Digital Early Pregnancy Test (K251053) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K150022 | Wondfo One Step HCG Urine Pregnancy Test Strip, Wondfo One ... | Guangzhou Wondfo Biotech Co., Ltd. | 2015 |
Trace the full predicate network for K251053
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.