# K953014: Alastat Microplate Latex-Specific Ige Allergen

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Aug 15, 1995 after 47 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.
5 later devices descend from it; 1 cites it directly.
0 of 6 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
- K962976: Pharmacia Cap System Rast Feia (1996), 4 descendants of its own
- K972068: Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82 (1997), 3 descendants of its own
- K030590: Cla Allergen-Specific Ige Assay-Latex Allergen (K82) (2003), 1 descendant of its own
- K121463: Immunocap Allergen K82 (2013), 0 descendants of its own
- K051677: Optigen Allergen Specific Ige Assay (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K953014
Methodology: https://510kreport.com/methodology