# K970477: Hyragel Iso-LDH Kit/Hydragel 15 Iso-LDH Kit

- Pathway: 510(k) (Traditional)
- Applicant: Sebia
- Decided: Mar 10, 1997 after 31 days
- Product code: CFE (Electrophoretic, Lactate Dehydrogenase Isoenzymes)
- Device class: 2
- Regulation: 21 CFR 862.1445
- 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Source page: https://510kreport.com/device/K970477
Methodology: https://510kreport.com/methodology