- Device
- BREATH TEK UBT FOR H PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION(PUHR-CA)
- Applicant
- Meridian Bioscience, Inc.
- PMA number
- P100025
- Supplement
- S002
- Product code
- OZA
- Generic name
- Test, urea adult and pediatric (breath),
- Decision date
- 2013-05-23
- Decision code
- APPR
- Date received
- 2012-08-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SHARP CORPORATION, IN ALLENTOWN, PA.