# K974350: Allergan Immuno Cap M4, M8, K70

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia, Inc.
- Decided: Feb 9, 1998 after 82 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) Phadebas RAST® Allergen Discs m4 Mucor racemosus, m8 Helminthosporium halodes and k70 Green Coffee Bean used with Phadebas RAST® immunodiagnostic test system: 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 ImmunoCAP™ are intended to be used with Pharmacia CAP System™ RAST FEIA and UniCAP™ Specific IgE in vitro diagnostic assays. It is intended for in vitro diagnostic use as an aid in the clinical diagnosis of Igk mediated allergic disorders in con;t,mctlon with other findings, and is to be used in clinical laboratories, as well as, physician office laboratories.

Source page: https://510kreport.com/device/K974350
Methodology: https://510kreport.com/methodology