# K941596: Remedi HS Drug Profiling System

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Rad
- Decided: Mar 27, 1995 after 360 days
- Product code: DNI (Liquid Chromatography, Amphetamine)
- Device class: 2
- Regulation: 21 CFR 862.3100
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 1 cites it directly.
0 of 7 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
- K043341: Bioplex 2200 Ana Screen with Medical Decision Support Software for Use with Bioplex 2200 Multi-Analyte Detection System (2005), 5 descendants of its own
- K080896: Pathwork Diagnostics Tissue of Origin Test (2008), 3 descendants of its own
- K092967: Pathwork Tissue of Origin Test Kit-Ffpe (Origin Test Kit-Ffpe (2010), 2 descendants of its own
- K120489: Tissue of Origin Test Kit Ffpe (2012), 1 descendant of its own
- K173839: Tissue of Origin Test Kit-FFPE (2018), 0 descendants of its own

Source page: https://510kreport.com/device/K941596
Methodology: https://510kreport.com/methodology