# K791393: Histoplasma Yeast Anti #CF10021X

- Pathway: 510(k) (Traditional)
- Applicant: Immuno-Mycologics, Inc.
- Decided: Aug 16, 1979 after 36 days
- Product code: GMJ (Antigens, Histoplasma Capsulatum, All)
- Device class: 2
- Regulation: 21 CFR 866.3320
- Recalls of this device: 1 (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
- May 9, 2016 · Class II · Z-2040-2016: The device was found to have bacterial contamination.

Source page: https://510kreport.com/device/K791393
Methodology: https://510kreport.com/methodology