# K983954: Alastat Microplate Mixed Allergen Panels

- Pathway: 510(k) (Traditional)
- Applicant: Diagnostic Products Corp.
- Decided: Dec 17, 1998 after 42 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) AlaSTAT Microplate Allergen-Specific IgE: named in the summary without a submission number

## Indications for use
AlaSTAT Microplate Allergen-Specific IgE is a kinetic enzyme immunometric assay system designed for the measurement of allergen-specific IgE 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/K983954
Methodology: https://510kreport.com/methodology