# K963245: Immulite Latex-Specific Ige

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Nov 18, 1996 after 91 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
Longest line of descent: 1 generation back to K931746 (1995). 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)
- K931746: Latex (K82), Diagnostic Products Corp. (1995) Summary page 1.
- (no number) AlaSTAT Microplate Latex-Specific IgE Allergen: named in the summary without a submission number

## Indications for use
DPC's IMMULITE Latex-Specific IgE is designed for the semi-quantitative detection of IgE antibodies specific to latex allergen in serum. It is intended strictly for in vitro diagnostic use as an aid in the clinical diagnosis of IgE-mediated allergic disorders.

Source page: https://510kreport.com/device/K963245
Methodology: https://510kreport.com/methodology