Class Class II
VITEK 2 AST-Gram Negative Cefazolin (<=1 - >=32 ug/mL) (K222073)
Description
VITEK 2 AST-Gram Negative Cefazolin (=32 ug/mL) by bioMerieux, Inc., an FDA 510(k) cleared microbiology device.
Regulatory Information
Device ClassClass Class II
510(k) NumberK222073
Clearance Date2023-02-09
Clearance TypeTraditional
Product CodeLON
Regulation Number866.1645
FDA Database
View on FDA DatabaseCategories
Predicate lineage for K222073
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 Cefazolin (<=1 - >=32 ug/mL) (K222073) cites 1 predicate device and is itself cited by 1 later device.
Predicate devices cited by this clearance
| K number | Device | Applicant | Year |
|---|---|---|---|
| K213931 | VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL) | bioMerieux, Inc. | 2022 |
Later devices that cite this one as their predicate
| K number | Device | Applicant | Year |
|---|---|---|---|
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL) | bioMerieux, Inc. | 2025 |
Trace the full predicate network for K222073
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.