BREATH TEK UBTFOR H. PYLORI KIT
FDA premarket approval P100025/S001 · decided 2012-09-05
Approval details
- PMA number
- P100025
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- BREATH TEK UBTFOR H. PYLORI KIT
- Generic name
- Test, urea adult and pediatric (breath),
- Applicant
- Meridian Bioscience, Inc.
- Date received
- 2012-03-19
- Decision date
- 2012-09-05
- Days to decision
- 170 days
- Decision code
- APPR
- Product code
- OZA
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- APPROVAL FOR PACKAGING CHANGES FOR THE BREATHTEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0. THE PACKAGING CHANGES CONSIST OF NEW KIT AND SHIPPER CARTONS ALONG WITH NEW LABELING ON THE EACH OF THESE CARTONS.
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