PMA P100025S012
- Device
- BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
- Applicant
- Meridian Bioscience, Inc.
- PMA number
- P100025
- Supplement
- S012
- Product code
- OZA
- Decision date
- 2017-03-30
- Classification
- Test, Urea Adult And Pediatric (breath),
- Generic name
- Test, urea adult and pediatric (breath),
- Approval order statement
- Approval for software upgrade from Version 1.1 to Version 2.0
Current openFDA PMA Record#
- Device
- BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
- Applicant
- Meridian Bioscience, Inc.
- PMA number
- P100025
- Supplement
- S012
- Product code
- OZA
- Generic name
- Test, urea adult and pediatric (breath),
- Decision date
- 2017-03-30
- Decision code
- APPR
- Date received
- 2017-01-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software upgrade from Version 1.1 to Version 2.0