FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Test, Urea Adult And Pediatric (Breath),
PMA: P100025
·
Supplement: S012
·
Decision Mar 30, 2017
Classifications
1
FEI Numbers
4
Registration Numbers
4
Basic Information
- Device Name
- Test, Urea Adult And Pediatric (Breath),
- Trade Name
- BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
- PMA Number
- P100025
- Supplement Number
- S012
- Device Class
- FDA Class 3
- Product Code
- OZA
- Generic Name
- Test, urea adult and pediatric (breath),
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Advisory Committee
- Microbiology
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- March 30, 2017
- Date Received
- January 9, 2017
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
Approval for software upgrade from Version 1.1 to Version 2.0
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OZA | Test, Urea Adult And Pediatric (Breath), | FDA class 3 | Microbiology |