# K983880: Transferrin SPQ Iii Antibody Reagent Set

- Pathway: 510(k) (Traditional)
- Applicant: DiaSorin, Inc.
- Decided: Dec 18, 1998 after 46 days
- Product code: DDG (Transferrin, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5880
- 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 its predicate without a number.
- (no number) SPQ™ Antibody Reagent Set II for Transferrin: named in the summary without a submission number

## Indications for use
FOR IN VITRO DIAGNOSTIC USE. The Transferrin SPQTM III ANTIBODY REAGENT SET is designed for the quantitative determination of transferrin in human serum by immunoprecipitin analysis.

Source page: https://510kreport.com/device/K983880
Methodology: https://510kreport.com/methodology