# K974580: Allergen Immunocap F256,F245,F207,F202

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia & Upjohn Co.
- Decided: Feb 9, 1998 after 63 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 K894190 (1990). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K894190: Pharmacia Cap System Rast Ria & Rast Feia, Pharmacia, Inc. (1990) Summary page 2.
- K911903: Allergans Pharmacia Cap Sys.Rast Ria/Feia, Pharmacia, Inc. (1991) Summary page 2.
- K962274: Unicap 100, Pharmacia, Inc. (1996) Summary page 2.

## Most influential descendants
- K150854: ImmunoCAP Specific IgE; ImmunoCAP Allergen f439, Hazelnut; ImmunoCAP Allergen f440, Hazelnut; ImmunoCAP Allergen f441, Walnut; ImmunoCAP Allergen f442, Walnut; ImmunoCAP Allergen f443, Cashew nut (2015), 0 descendants of its own

## 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.

Source page: https://510kreport.com/device/K974580
Methodology: https://510kreport.com/methodology