PMA P100025S010

Device: BREATH TEK UBT FOR H.PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA
Applicant: Meridian Bioscience, Inc.
PMA number: P100025
Supplement: S010
Product code: OZA
Decision date: 2016-01-27
Classification: Test, Urea Adult And Pediatric (breath),
Generic name: Test, urea adult and pediatric (breath),
Approval order statement: APPROVAL FOR LABELING CHANGES TO THE PACKAGE INSERT AND THE HOW TO GUIDE FOR THE BREATHTEK® UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA).

Current openFDA PMA Record#

Device: BREATH TEK UBT FOR H.PYLORI KIT (BREATH TEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA
Applicant: Meridian Bioscience, Inc.
PMA number: P100025
Supplement: S010
Product code: OZA
Generic name: Test, urea adult and pediatric (breath),
Decision date: 2016-01-27
Decision code: APPR
Date received: 2015-09-15
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR LABELING CHANGES TO THE PACKAGE INSERT AND THE HOW TO GUIDE FOR THE BREATHTEK® UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA).