# K993437: K-Assay C3

- Pathway: 510(k) (Traditional)
- Applicant: Kamiya Biomedical Co.
- Decided: Nov 24, 1999 after 43 days
- Product code: CZW (Complement C3, 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 Complement C3 Assay is intended to be used for the quantitative determination of Complement C3 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. FOR IN VITRO DIAGNOSTIC USE.

Source page: https://510kreport.com/device/K993437
Methodology: https://510kreport.com/methodology