BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
FDA premarket approval P100025 · decided 2012-02-22
Approval details
- PMA number
- P100025
- Trade name
- BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
- Generic name
- Test, urea adult and pediatric (breath),
- Applicant
- Meridian Bioscience, Inc.
- Date received
- 2010-06-22
- Decision date
- 2012-02-22
- Days to decision
- 610 days
- Decision code
- APWD
- Product code
- OZA
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- APPROVAL FOR THE BREATHTEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0. THE BREATHTEK UBT KIT IS CURRENTLY CLEARED FOR USE INADULT PATIENTS UNDER 510(K) PREMARKET NOTIFICATION, K014225, AND THE PRANACTIN-CITRIC IS APPROVED UNDER NDA 20-586/S-004. THIS DEVICE IS INDICATED FOR: THE BREATHTEK UBT FOR H PYLORI KIT (BREATHTEK UBT KIT) IS INTENDED FOR USE IN THE QUALITATIVE DETECTION OF UREASE ASSOCIATED WITH H. PYLORI IN
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