# K943592: Chemstrip Mini UA Urine Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Nov 8, 1994 after 106 days
- Product code: KQO (Automated Urinalysis System)
- Device class: 1
- Regulation: 21 CFR 862.2900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 1 cites it directly.
0 of 15 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
- K983510: Chemstrip 101 Urine Analyzer (1998), 13 descendants of its own
- K013783: Aution Max AX-4280 Urinalysis System (2002), 11 descendants of its own
- K093098: Aution Max Model AX-4030 Urinalysis System (2009), 4 descendants of its own
- K101852: Chem Velocity Automated Urine Chemistry System, Strips and Calchek Kit (2011), 3 descendants of its own
- K171083: iChemVELOCITY Automated Urine Chemistry System (2017), 2 descendants of its own

Source page: https://510kreport.com/device/K943592
Methodology: https://510kreport.com/methodology