FDA PMA
FDA Class 3
Approved
🇺🇸 United States
Test, Urea Adult And Pediatric (Breath),
PMA: P100025
·
Supplement: S003
·
Decision Nov 6, 2012
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 HIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE APPLICATION (PUHR-CA)
- PMA Number
- P100025
- Supplement Number
- S003
- 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
- November 6, 2012
- Date Received
- October 12, 2012
- Supplement Type
- Special (Immediate Track)
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A LABELING CHANGE TO ENHANCE THE SAFE USE OF THE DEVICE.
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 |