Device Listing 1993667191
Listing Summary#
- Listing key
- 1993667191
- Premarket submission
- P100025
- Device
- BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
- Applicant
- OTSUKA AMERICA PHARMACEUTICAL, INC.
- Product code
- OZA
- Decision date
- 2012-02-22