# K955345: LMD Cryptosporidium Antigen Detection

- Pathway: 510(k) (Traditional)
- Applicant: Lmd Laboratories
- Decided: Jun 7, 1996 after 199 days
- Product code: MHJ (Cryptosporidium Spp.)
- Device class: 2
- Regulation: 21 CFR 866.3220
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K031059: Ivd Cryptosporidium Antigen Detection Assay, Model CP-96 (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K955345
Methodology: https://510kreport.com/methodology