# K992488: Total Haemolytic Complement Rid Kit

- Pathway: 510(k) (Traditional)
- Applicant: The Binding Site, Ltd.
- Decided: Sep 17, 1999 after 53 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
For measuring human haemolytic complement activity by the classical pathway in human serum, as an aid in diagnosis of immunological disorders, especially those associated with complement component deficiencies.

Source page: https://510kreport.com/device/K992488
Methodology: https://510kreport.com/methodology