# K982343: Allergen Immunocap Models D73, D74, E71, E72, E73, E74 E75, E76,E82,E88, F48, F90, F92, F96, F201, F215, M70, T17, T72,3

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia & Upjohn Co.
- Decided: Sep 15, 1998 after 71 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, Specific Allergen Modules: named in the summary without a submission number

## Indications for use
Allergen ImmunoCAP™ is the solid phase component of the Pharmacia & Upjohn in vitro immunodiagnostic systems which measure specific IgE to the respective allergen bound to the InmunoCAP. Allergen InmunoCAP are intended to be used with Pharmacia CAP System RAST FEIA and UniCAP Specific IgE in vitro diagnostic assays. Pharmacia CAP System RAST FEIA and UniCAP Specific IgE are intended for in vitro diagnostic use as an aid in the clinical diagnosis of IgE mediated allergic disorders in conjunction with other findings, and are to be used in clinical laboratories, as well as, physician office laboratories.

Source page: https://510kreport.com/device/K982343
Methodology: https://510kreport.com/methodology