# K890530: N Latex Ige Kit (Immunoglobulin E Reagents)

- Pathway: 510(k) (Traditional)
- Applicant: Behring Diagnostics, Inc.
- Decided: Mar 27, 1989 after 53 days
- Product code: DGC (Ige, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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.

## Most influential descendants
- K991787: N Latex Ige Mono Reagent (1999), 1 descendant of its own
- K063425: Dimension Vista Ige Flex Reagent Cartridge, Protein 1 Calibrator, Protein 1 Control Medium, and Protein 1 Control High (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K890530
Methodology: https://510kreport.com/methodology