# K932373: Hemagen Cardiolipin Antibody Kit (Eia METHOD0

- Pathway: 510(k) (Traditional)
- Applicant: Hemagen Diagnostics, Inc.
- Decided: Jul 16, 1993 after 60 days
- Product code: MID (System, Test, Anticardiolipin Immunological)
- Device class: 2
- Regulation: 21 CFR 866.5660
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 4 cite it directly.
0 of 5 devices 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.

## Most influential descendants
- K992241: Virgo B2 Glycoprotein I Iga Antibody Kit (1999), 0 descendants of its own
- K992243: Virgo Beta 2 Glycoprotein Igm Antibody Kit (1999), 0 descendants of its own
- K992224: Virgo Beta 2 Glycoprotein Igg Antibody Kit (1999), 0 descendants of its own
- K971039: Hemagen Anti Cardiolipin Screen (1997), 0 descendants of its own

Source page: https://510kreport.com/device/K932373
Methodology: https://510kreport.com/methodology