# K964718: Sta D-DI Calibrator Kit

- Pathway: 510(k) (Traditional)
- Applicant: American Bioproducts Co.
- Decided: May 23, 1997 after 179 days
- Product code: DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 864.7320
- 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. The FDA summary names no predicate by number.

## Indications for use
The STA® D-Di Calibrator kit is intended for use as a calibration plasma for D-dimer antigen assays by the immuno-turbidimetric method performed on STA® analyzers (Diagnostica Stago, France: STA® full-size model, K942117; STA® Compact model, K961579).

Source page: https://510kreport.com/device/K964718
Methodology: https://510kreport.com/methodology