# K810863: Kallestad Hep-2 Cell Line Substrate

- Pathway: 510(k) (Traditional)
- Applicant: Kallestad Laboratories, Inc.
- Decided: Apr 14, 1981 after 14 days
- Product code: DBM (Antimitochondrial Antibody, Indirect Immunofluorescent, Antigen, Control)
- Device class: 2
- Regulation: 21 CFR 866.5090
- 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
- Jul 29, 2008 · Not classified · Z-2428-2008: The Homogeneous Positive control was released with a titer of 1:256 rather than the titer value of 1:128 reported on the QC Report Label included with each test kit.

Source page: https://510kreport.com/device/K810863
Methodology: https://510kreport.com/methodology