Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series (K230790)
Description
Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series by Abbott Laboratories, an FDA 510(k) cleared clinical chemistry device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K230790
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. Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-series (K230790) cites 3 predicate devices and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K170320 | Alinity c ICT Sample Diluent | Abbott Laboratories | 2017 |
| K170317 | Alinity i Total ß-hCG Reagent Kit, Alinity i System | Abbott Laboratories | 2017 |
| K170316 | ALINITY C GLUCOSE REAGENT KIT, ALINITY C SYSTEM | Abbott Laboratories | 2017 |
Trace the full predicate network for K230790
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.