# K983132: IGM

- Pathway: 510(k) (Traditional)
- Applicant: Abbott Laboratories
- Decided: Nov 4, 1998 after 57 days
- Product code: DFT (Igm, Antigen, Antiserum, Control)
- Device class: 2
- Regulation: 21 CFR 866.5550
- Recalls of this device: 2 (0 Class I)
- 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 has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- May 16, 2018 · Class II · Z-1990-2019: An update to the Reagents and Specimen Collection and Handling/Preparation for Analysis sections of the IFU was required due to different issues with the various products.
- Nov 10, 2005 · Not classified · Z-0384-06: These specific protein assays are not meeting the 57-day on board stability claim

Source page: https://510kreport.com/device/K983132
Methodology: https://510kreport.com/methodology