Class Class II
ARCHITECT iGentamicin (K243500)
Description
ARCHITECT iGentamicin by Abbott Laboratories, an FDA 510(k) cleared clinical toxicology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK243500
Clearance Date2025-07-09
Clearance TypeSpecial
Product CodeLCD
Regulation Number862.3450
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K243500
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. ARCHITECT iGentamicin (K243500) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K102699 | ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIB... | Abbott Laboratories | 2011 |
Trace the full predicate network for K243500
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.