# K924979: Immunocard (TM) C. Difficile

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Diagnostics, Inc.
- Decided: Jan 26, 1993 after 117 days
- Product code: LLH (Reagents, Clostridium Difficile Toxin)
- Device class: 1
- Regulation: 21 CFR 866.2660
- 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; 2 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
- K053572: C. Diff Quik Chek (2006), 3 descendants of its own
- K132010: Vidas C Difficile GDH (2013), 0 descendants of its own
- K112048: Immunocard C. Difficile GDH (2011), 0 descendants of its own
- K082499: C. Diff Quik Chek Complete (2009), 0 descendants of its own

Source page: https://510kreport.com/device/K924979
Methodology: https://510kreport.com/methodology