# K964298: N-Assay Tia Multi V-NL

- Pathway: 510(k) (Traditional)
- Applicant: Crestat Diagnostics, Inc.
- Decided: Jul 14, 1997 after 258 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.
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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K983441: C3 (1998), 0 descendants of its own

## Indications for use
The N-Assay TIA C3 Test Kit is intended to be used for the quantitation of C3 in human serum by immunoturbidimetric assay. The measurement of C3 aids in the diagnosis of immunological disorders, especially those associated with deficiencies of complement components.

Source page: https://510kreport.com/device/K964298
Methodology: https://510kreport.com/methodology