# K974111: Quidel CH50 EQ Eia

- Pathway: 510(k) (Traditional)
- Applicant: Quidel Corp.
- Decided: Jul 29, 1998 after 271 days
- Product code: DAE (Complement C9, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5240
- 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 no predicate by number.

## Indications for use
The QUIDEL CH50 Eq EIA intended to measure the total classical complement pathway activity in human serum, thereby allowing detection of a deficiency of one or more of the complement components C1 through C9. The QUIDEL CH50 Eq EIA is intended for laboratory and professional use.

Source page: https://510kreport.com/device/K974111
Methodology: https://510kreport.com/methodology