Class Class II
Quantia IgE (K214068)
Description
Quantia IgE by Biokit, S.A., an FDA 510(k) cleared immunology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK214068
Clearance Date2023-02-21
Clearance TypeSpecial
Product CodeDGC
Regulation Number866.5510
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K214068
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. Quantia IgE (K214068) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K050493 | QUANTIA IGE | Biokit, S.A. | 2005 |
Trace the full predicate network for K214068
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.