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 | 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), |
Regulation Number | 866.3110 |
Applicant | Meridian Bioscience, Inc. 3471 River Hills Drive Cincinnati, OH 45244 |
PMA Number | P100025 |
Supplement Number | S004 |
Date Received | 02/01/2013 |
Decision Date | 05/29/2013 |
Product Code |
OZA |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGES TO THE LABELING FOR THE BREATHTEK® UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0, INCLUDING THE PACKAGE INSERT AND HOW TO GUIDE. |
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