# K911511: Alastat Allergen Specified Ige System, Modified

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Apr 17, 1991 after 13 days
- Product code: DGO (Ige, Peroxidase, 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.
13 later devices descend from it; 3 cite it directly.
0 of 14 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
- K013134: Immulite 2000 Allergen-Specific Ige and Specific Allergens, Mdoel L2KUN6 (600 Tests) (2001), 10 descendants of its own
- K013135: Immunlite 2000 Allergen-Specific Ige and Mixed Allergen Panels, Model L2KUN6 (600 Tests) (2001), 8 descendants of its own
- K101572: Immulite 2000 3GALLERGY Specific Ige Assay Kit (2011), 2 descendants of its own
- K093987: Immulite 2000 3G Allergy Specific Ige Assay Kit Model L2KUN6 (2011), 2 descendants of its own
- K112523: Immulite 2000 3GALLERGY Specific Ige Assay Kit (2012), 1 descendant of its own

Source page: https://510kreport.com/device/K911511
Methodology: https://510kreport.com/methodology