# K970250: Clinistrip

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics
- Decided: Apr 8, 1997 after 76 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K170118: Scanostics UTI Check Application Test System (2017), 0 descendants of its own

## Indications for use
C//@/J’//})o 0 @4 Ere. mlend 7o pProvady, 5%/7(/3&7‘/

Source page: https://510kreport.com/device/K970250
Methodology: https://510kreport.com/methodology