# K803025: CDC Anaerobe Blood Agar

- Pathway: 510(k) (Traditional)
- Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
- Decided: Dec 22, 1980 after 26 days
- Product code: JSG (Culture Media, Non-Selective And Non-Differential)
- Device class: 1
- Regulation: 21 CFR 866.2300
- Recalls of this device: 2 (0 Class I)
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Jun 6, 2014 · Class II · Z-0975-2015: A low level of surface and subsurface contamination of Listeria monocytogenes on 9 lots of non-sterile prepared plated media containing sheep blood, typically visible immediately upon removal from the
- Mar 11, 2013 · Class II · Z-1334-2013: Microbiological media may be contaminated with bacteria.

Source page: https://510kreport.com/device/K803025
Methodology: https://510kreport.com/methodology