LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer (K242830)
Description
LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer by Bonraybio Co., Ltd., an FDA 510(k) cleared hematology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K242830
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. LensHooke X3 PRO Semen Quality Analyzer; LensHooke X3 PRO SE Semen Quality Analyzer (K242830) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K202089 | LensHooke X1 PRO Semen Quality Analyzer, LensHooke X1 PRO S... | Bonraybio Co., Ltd. | 2020 |
Trace the full predicate network for K242830
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.