# K896454: Chemstrip (R) 10 with SG Urine Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Boehringer Mannheim Corp.
- Decided: Jan 11, 1990 after 63 days
- Product code: JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative))
- Device class: 2
- Regulation: 21 CFR 862.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
7 later devices descend from it; 3 cite it directly.
0 of 8 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
- K040703: Uristik H Series Reagent Strips for Urinalysis (2004), 3 descendants of its own
- K990206: Serim Blood Leak Test Strip (1999), 2 descendants of its own
- K082811: Uritest 10G & 11G Urine Reagent Strips and Uritest-50 and Uritest-500B Urine Analyzers (2009), 1 descendant of its own
- K012115: Serim Blood Leak Test Strip-2 (2001), 1 descendant of its own
- K232317: UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K896454
Methodology: https://510kreport.com/methodology