# K991945: Pharmacia Cap System Ige Feia, Model 10-9395-01

- Pathway: 510(k) (Traditional)
- Applicant: Pharmacia & Upjohn Co.
- Decided: Jul 28, 1999 after 49 days
- Product code: DGC (Ige, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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) Pharmacia CAP System IgE FEIA: named in the summary without a submission number

## Most influential descendants
- K032251: Immunetech Total Ige System (2003), 0 descendants of its own

## Indications for use
Pharmacia CAP System IgE FEIA is an in vitro test system for the guantitative measurement of circulating total IgE in human blood samples.

Source page: https://510kreport.com/device/K991945
Methodology: https://510kreport.com/methodology