VITEK 2 AST-Gram Negative Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (K222430)
Description
VITEK 2 AST-Gram Negative Fosfomycin (=256 µg/mL), VITEK 2 AST-GN Fosfomycin (=256 µg/mL), VITEK 2 AST-GN Fosfomycin by Biomerieux Sa, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
FDA Database
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Predicate lineage for K222430
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 Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (<=4 - >=256 µg/mL), VITEK 2 AST-GN Fosfomycin (K222430) cites 1 predicate device and is itself cited by 0 later devices.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K191766 | VITEK 2 AST-Gram Negative Eravacycline (<=0.12 - >=4µg/mL) | bioMerieux, Inc. | 2019 |
Trace the full predicate network for K222430
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.