BreathTek UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)
FDA premarket approval P100025/S014 · decided 2020-05-26
Approval details
- PMA number
- P100025
- Supplement
- S014
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BreathTek UBT for H. pylori Kit and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)
- Generic name
- Test, urea adult and pediatric (breath),
- Applicant
- Meridian Bioscience, Inc.
- Date received
- 2019-08-12
- Decision date
- 2020-05-26
- Days to decision
- 288 days
- Decision code
- APPR
- Product code
- OZA
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- Approval of new manufacturing facility.
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