# K954932: BBL Mgit Products

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Diagnostic Instrument Systems
- Decided: Aug 21, 1996 after 299 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 System: named in the summary without a submission number
- (no number) BBL® SEPTI-CHEK® AFB Mycobacteria Culture System: named in the summary without a submission number

## Indications for use
The BBL® MGIT™ Mycobacteria Growth Indicator Tube supplemented with BBL® MGIT™ OADC and BBL® MGIT™ PANTA antibiotic, mixture, when appropriate, is intended for the detection and recovery of mycobacteria. Acceptable specimen types are digested and decontaminated clinical specimens (except urine) and sterile body fluids (except blood).

Source page: https://510kreport.com/device/K954932
Methodology: https://510kreport.com/methodology