PMA P100025
- Device
- BreathTek UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)
- Applicant
- Meridian Bioscience, Inc.
- PMA number
- P100025
- Supplement
- S014
- Product code
- OZA
- Decision date
- 2020-05-26
- Generic name
- Test, urea adult and pediatric (breath),
- Approval order statement
- Approval of new manufacturing facility.
Current openFDA PMA Record#
- Device
- BreathTek UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)
- Applicant
- Meridian Bioscience, Inc.
- PMA number
- P100025
- Supplement
- S014
- Product code
- OZA
- Generic name
- Test, urea adult and pediatric (breath),
- Decision date
- 2020-05-26
- Decision code
- APPR
- Date received
- 2019-08-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval of new manufacturing facility.