# K946268: Bactec (R) 9000TB System

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Diagnostic Instrument Systems
- Decided: May 21, 1996 after 515 days
- Product code: MDB (System, Blood Culturing)
- Device class: 1
- Regulation: 21 CFR 866.2560
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Bactec® 460TB: named in the summary without a submission number

## Indications for use
Detection of mycobacteria in clinical respiratory specimens

Source page: https://510kreport.com/device/K946268
Methodology: https://510kreport.com/methodology