PMA P100025S005
- Device
- BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)
- Applicant
- Meridian Bioscience, Inc.
- PMA number
- P100025
- Supplement
- S005
- Product code
- OZA
- Decision date
- 2014-04-18
- Classification
- Test, Urea Adult And Pediatric (breath),
- Generic name
- Test, urea adult and pediatric (breath),
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE POCONE INFRARED SPECTROPHOTOMETER FOR PEDIATRIC USE.
Current openFDA PMA Record#
- Device
- BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)
- Applicant
- Meridian Bioscience, Inc.
- PMA number
- P100025
- Supplement
- S005
- Product code
- OZA
- Generic name
- Test, urea adult and pediatric (breath),
- Decision date
- 2014-04-18
- Decision code
- APPR
- Date received
- 2013-06-28
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE POCONE INFRARED SPECTROPHOTOMETER FOR PEDIATRIC USE.