# P920031: Emit 2000 Cyclosporine Specific Assay

- Pathway: PMA
- Applicant: Dade Behring, Inc.
- Decided: Oct 2, 1996 after 1,556 days
- Product code: MKW (Cyclosporine)
- Device class: 2
- Regulation: 21 CFR 862.1235
- 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. PMA decisions do not claim a predicate device.

## Most influential descendants
- K023208: Cedia Cyclosporine Plus Assay (2002), 0 descendants of its own

Source page: https://510kreport.com/device/P920031
Methodology: https://510kreport.com/methodology