Class Class II
Selux AST System; Model AST Gen 1.0 (K211759)
Description
Selux AST System; Model AST Gen 1.0 by Selux Diagnostics, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK211759
Clearance Date2023-01-18
Clearance TypeTraditional
Product CodeLON
Regulation Number866.1645
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K211759
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. Selux AST System; Model AST Gen 1.0 (K211759) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K131331 | BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - VANCOMYCIN (0.5-... | Becton, Dickinson & CO | 2013 |
Trace the full predicate network for K211759
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.