# K954566: Specific Allergen Modules for the Alastat Microplate Allergen-Specific Ige System

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Dec 18, 1995 after 77 days
- Product code: DHB (System, Test, Radioallergosorbent (Rast) Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 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
- K973186: Immulite Cat-Specific Ige, Immulite Dog-Specific Ige,Immulite Mite-Specific Ige (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K954566
Methodology: https://510kreport.com/methodology