BREATH TEK UBT FOR H PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION(PUHR-CA)
FDA premarket approval P100025/S002 · decided 2013-05-23
Approval details
- PMA number
- P100025
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- BREATH TEK UBT FOR H PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION(PUHR-CA)
- Generic name
- Test, urea adult and pediatric (breath),
- Applicant
- Meridian Bioscience, Inc.
- Date received
- 2012-08-31
- Decision date
- 2013-05-23
- Days to decision
- 265 days
- Decision code
- APPR
- Product code
- OZA
- Advisory committee
- Microbiology
- Expedited review
- No
- Location
- Cincinnati, OH
- Statement
- APPROVAL FOR A MANUFACTURING SITE LOCATED AT SHARP CORPORATION, IN ALLENTOWN, PA.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Revogene (K243922) | Meridian Bioscience, Inc. | 2025-03-20 |
| Premier HpSA Flex (619096) (K230901) | Meridian Bioscience, Inc. | 2023-07-03 |
| Curian® Shiga Toxin (K222829) | Meridian Bioscience, Inc. | 2023-04-17 |
| Revogene (K222779) | Meridian Bioscience, Inc. | 2023-01-26 |
| Revogene (K220480) | Meridian Bioscience, Inc. | 2022-07-11 |
| Curian Campy (K210976) | Meridian Bioscience, Inc. | 2021-12-23 |
| Curian HpSA, Curian Analyzer (K192817) | Meridian Bioscience, Inc. | 2020-03-13 |
| Alethia CMV DNA Amplification Assay, Alethia CMV External Control Kit (DEN180040) | Meridian Bioscience, Inc. | 2018-11-30 |