Class Class II
Tacrolimus Assay Kit (K203833)
Description
Tacrolimus Assay Kit by Shanghai Genext Medical Technology Co., Ltd., an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK203833
Clearance Date2023-01-27
Clearance TypeTraditional
Product CodeMLM
Regulation Number862.1678
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K203833
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. Tacrolimus Assay Kit (K203833) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K070820 | ARCHITECT TACROLIMUS: MODEL 1L77 | Fujirebio Diagnostics,Inc. | 2007 |
Trace the full predicate network for K203833
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.