# K912408: Merifluor-Cryptosporidium/Giardia

- Pathway: 510(k) (Traditional)
- Applicant: Meridian Diagnostics, Inc.
- Decided: Jul 24, 1991 after 54 days
- Product code: MHI (Giardia 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.
4 later devices descend from it; 3 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K051929: Giardia/Cryptosporidium Chek (2005), 1 descendant of its own
- K171078: Tri-Combo Parasite Screen (2017), 0 descendants of its own
- K103673: Giardia/ Cryptosporidium Quik Chek (2011), 0 descendants of its own
- K024113: Ivd Crypto/Giardia Dfa (2003), 0 descendants of its own

Source page: https://510kreport.com/device/K912408
Methodology: https://510kreport.com/methodology