# K023297: Urs-1B (Blood Test)

- Pathway: 510(k) (Traditional)
- Applicant: Teco Diagnostics
- Decided: Mar 6, 2003 after 155 days
- Product code: JIO (Blood, Occult, Colorimetric, In Urine)
- Device class: 2
- Regulation: 21 CFR 864.6550
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Indications for use
The TECO Diagnostics URS-1B (Blood Test) is intended for “Professional Use.” The test is used, by professional people, for a qualitative determination of blood in human urine. Urinary blood measurements are used in the diagnosis and treatment of hematuria and glomerulonephritis.

Source page: https://510kreport.com/device/K023297
Methodology: https://510kreport.com/methodology