VITEK® 2 AST-Gram Negative Plazomicin (=0.5 – =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 – =16 µg/mL); VITEK® 2 AST-GN Plazomicin (K223478)
Description
VITEK® 2 AST-Gram Negative Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 - =16 µg/mL); VITEK® 2 AST-GN Plazomicin by bioMerieux, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K223478
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. VITEK® 2 AST-Gram Negative Plazomicin (=0.5 – =16 µg/mL); VITEK® 2 AST-GN Plazomicin (=0.5 – =16 µg/mL); VITEK® 2 AST-GN Plazomicin (K223478) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K163563 | VITEK 2 AST-GN Gentamicin (<=1 >=16 µg/mL) | bioMerieux, Inc. | 2017 |
Trace the full predicate network for K223478
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.