# K945195: Abuscreen Online Propoxphene

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Dec 9, 1994 after 46 days
- Product code: JXN (Enzyme Immunoassay, Propoxyphene)
- Device class: 2
- Regulation: 21 CFR 862.3700
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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
- K983700: Modification to Abuscreen Online for Propoxyphene (1998), 1 descendant of its own
- K043303: Online Dat Propoxyphene Plus (2005), 0 descendants of its own

Source page: https://510kreport.com/device/K945195
Methodology: https://510kreport.com/methodology