# K993928: Wako-Igg II-HA, Immunoglobulin Calibrator Set, Immunolobulin Standard

- Pathway: 510(k) (Traditional)
- Applicant: Wako Chemicals USA, Inc.
- Decided: Jan 18, 2000 after 61 days
- Product code: DEW (Igg, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5510
- 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) Wako IgG HA-Direct product: named in the summary without a submission number

## Indications for use
Measurement of serum immunoglobulin levels to aid diagnosis of abnormal protein levels and the body's lack of ability to resist infectious agents

Source page: https://510kreport.com/device/K993928
Methodology: https://510kreport.com/methodology