# K951965: Dako Labeled Streptavidin-Biotin 2 Kit, and Envision

- Pathway: 510(k) (Traditional)
- Applicant: Dako Corp.
- Decided: Jul 5, 1996 after 435 days
- Product code: DEH (Lambda, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924726 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924726: Dako Mouse Anti-Human B-Cell (Dako-C020-L26 Mono Anti, Dako Corp. (1994) Summary page 1.

Source page: https://510kreport.com/device/K951965
Methodology: https://510kreport.com/methodology