# K970512: Bactec Myco/F Lytic Culture Vials

- Pathway: 510(k) (Traditional)
- Applicant: Becton Dickinson Microbiology Systems
- Decided: Jan 8, 1998 after 331 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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 13A Mycobacteria Culture Medium: named in the summary without a submission number

## Most influential descendants
- K222559: BD BACTEC™ Myco/F Lytic Culture Vials (2023), 0 descendants of its own

## Indications for use
The BACTEC ® MYCO/F LYTIC Culture vial when used with the BACTEC 9000MB System is a qualitative test for the culture and recovery of mycobacteria in human blood specimens from patients who are suspected of having septicemia.

Source page: https://510kreport.com/device/K970512
Methodology: https://510kreport.com/methodology