# K921087: Chemstrip Urine Analyzer

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Mar 24, 1992 after 18 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.
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 has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K093555: Cobas U411 Test System (2010), 1 descendant of its own
- K183432: cobas u 601 urinalysis test system (2019), 0 descendants of its own

Source page: https://510kreport.com/device/K921087
Methodology: https://510kreport.com/methodology