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Device | BREATHTEK UBT FOR H. PYLORI HIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE 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 | S003 |
Date Received | 10/12/2012 |
Decision Date | 11/06/2012 |
Product Code |
OZA |
Advisory Committee |
Microbiology |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A LABELING CHANGE TO ENHANCE THE SAFE USE OF THE DEVICE. |