PMA supplement
P100025 S004: BREATH TEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR
FDA PMA supplement · Normal 180 Day Track · Meridian Bioscience, Inc.
Key facts
| Original PMA | P100025 |
|---|---|
| Supplement number | S004 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | BREATH TEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR |
| Generic name | Test, urea adult and pediatric (breath), |
| Applicant | Meridian Bioscience, Inc. |
| Product code | OZA |
| Received date | Feb 1, 2013 |
| Decision date | May 29, 2013 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: