# P100025: Breathtek Ubt for H. Pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (Puhr-CA), Version 1.0

- Pathway: PMA
- Applicant: Meridian Bioscience, Inc.
- Decided: Feb 22, 2012 after 610 days
- Product code: OZA (Test, Urea Adult And Pediatric (Breath),)
- Device class: 3
- Regulation: 21 CFR 866.3110
- 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. PMA decisions do not claim a predicate device.

Source page: https://510kreport.com/device/P100025
Methodology: https://510kreport.com/methodology