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Device | BREATH TEK UBT FOR H PYLORI KIT (BREATH TEK 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 | S002 |
Date Received | 08/31/2012 |
Decision Date | 05/23/2013 |
Product Code |
OZA |
Advisory Committee |
Microbiology |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE LOCATED AT SHARP CORPORATION, IN ALLENTOWN, PA. |