# K964300: N-Assay Tia Multi V-NL

- Pathway: 510(k) (Traditional)
- Applicant: Crestat Diagnostics, Inc.
- Decided: Jul 14, 1997 after 258 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 N-Assay TIA Multi V-NL Calibrator is intended to be used to calibrate the Crestat N-Assay TIA test Kits N-Assay TIA C3 Test Kit, N-Assay C3 Test Kit, N-Assay Transferrin Test Kit, N-Assay Haptoglobin Test Kit, N-Assay Alpha-1-Acid Glycoprotein Test Kit. The test kits are to be run on human serum.

Source page: https://510kreport.com/device/K964300
Methodology: https://510kreport.com/methodology