# K113200: Vitek 2 Ast-GN Piperacillin/Tazobactam

- Pathway: 510(k) (Traditional)
- Applicant: bioMerieux, Inc.
- Decided: Jun 29, 2012 after 242 days
- Product code: LON (System, Test, Automated, Antimicrobial Susceptibility, Short Incubation)
- Device class: 2
- Regulation: 21 CFR 866.1645
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K211630: VITEK 2 AST-Gram Negative Piperacillin / Tazobactam (<=4 - =>128 µg/mL) (2021), 0 descendants of its own
- K163083: VITEK 2 AST-GN Tobramycin (</=1->/= 16 ug/mL); VITEK 2 AST-Gram Negative Tobramycin (</=1->/=16 ug/mL) (2017), 0 descendants of its own

Source page: https://510kreport.com/device/K113200
Methodology: https://510kreport.com/methodology