|
Device | BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA) |
Generic Name | Test, urea adult and pediatric (breath), |
Regulation Number | 866.3110 |
Applicant | Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati, OH 45244 |
PMA Number | P100025 |
Supplement Number | S006 |
Date Received | 01/22/2014 |
Decision Date | 02/19/2014 |
Product Code |
OZA |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE CHANGES TO THE RELEASING SPECIFICATION FOR 13C-UREA TO COMPLY WITH THE USP MONOGRAPH CHANGES. |