Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream (K242135)
Description
Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream by Nanjing Synthgene Medical Technology Co., Ltd., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242135
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. Synthgene Home Test HCG Test Strip; Synthgene Home Test HCG Test Cassette; Synthgene Home Test HCG Test Midstream (K242135) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K192123 | HIGHTOP Pregnancy Rapid Test Cassette, HIGHTOP Pregnancy Ra... | Qingdao Hightop Biotech Co., Ltd. | 2019 |
Trace the full predicate network for K242135
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.