# K993481: K-Assay C4

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Nov 29, 1999 after 46 days
- Product code: DBI (Complement C4, 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
The K-ASSAY C4 Assay is intended to be used for the quantitative determination of C4 in human serum by immunoturbidimetric assay. Complement is a group of serum proteins which destroy infectious agents. Measurement of these proteins aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components.

Source page: https://510kreport.com/device/K993481
Methodology: https://510kreport.com/methodology