Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit (K250549)
Description
Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit by The Binding Site Group , Ltd., an FDA 510(k) cleared immunology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K250549
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. Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free Kit (K250549) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K040009 | FREELITE HUMAN KAPPA AND LAMBDA KITS | The Binding Site, Ltd. | 2004 |
Trace the full predicate network for K250549
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.