Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | BREATHTEK UBT FOR H.PYLORI KIT (BREATHTEK UBT 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 | S005 |
Date Received | 06/28/2013 |
Decision Date | 04/18/2014 |
Product Code |
OZA |
Advisory Committee |
Microbiology |
Clinical Trials | NCT01623154
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Supplement Type | Normal 180 Day Track |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR THE ADDITION OF THE POCONE INFRARED SPECTROPHOTOMETER FOR PEDIATRIC USE. |
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