BREATHTEK UBT FOR H. PYLORI HIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE APPLICATION (PUHR-CA)
FDA premarket approval P100025/S003 · decided 2012-11-06
Approval details
- PMA number
- P100025
- Supplement
- S003
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BREATHTEK UBT FOR H. PYLORI HIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE APPLICATION (PUHR-CA)
- Generic name
- Test, urea adult and pediatric (breath),
- Applicant
- Meridian Bioscience, Inc.
- Date received
- 2012-10-12
- Decision date
- 2012-11-06
- Days to decision
- 25 days
- Decision code
- APPR
- Product code
- OZA
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- APPROVAL FOR A LABELING CHANGE TO ENHANCE THE SAFE USE OF THE DEVICE.
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