# K011400: Mrsa-Screen

- Pathway: 510(k) (Traditional)
- Applicant: Denka Seiken'S
- Decided: Mar 27, 2002 after 324 days
- Product code: MYI (System, Test, Genotypic Detection, Resistant Markers, Staphylococcus Colonies)
- Device class: 2
- Regulation: 21 CFR 866.1640
- 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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K062864: Mastalex -Mrsa, Model RST501 (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K011400
Methodology: https://510kreport.com/methodology