# K941573: Roche Reagent

- Pathway: 510(k) (Traditional)
- Applicant: Roche Diagnostic Systems, Inc.
- Decided: Oct 31, 1994 after 214 days
- Product code: CHH (Enzymatic Esterase--Oxidase, Cholesterol)
- Device class: 1
- Regulation: 21 CFR 862.1175
- 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; 1 cites 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
- K060854: Abx Pentra 400:  Lipoproteins (2006), 3 descendants of its own
- K103747: Elitech Clincal Systems Cholesterol HDL SL 2G, HDL 2G Calibrator, LDL SL 2G, LDL 2G Calibrator, Elitrol II & Elitech Sys (2011), 0 descendants of its own
- K102993: Elitech Clinical Systems Triglycerides SL, Elitech Clinical Systems Cholesterol SL (2011), 0 descendants of its own
- K062737: Cardiac Markers on Abx Pentra 400 Clinical Chemistry Analyzer (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K941573
Methodology: https://510kreport.com/methodology