PMA P100025S004

Device: BREATH TEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR
Applicant: Meridian Bioscience, Inc.
PMA number: P100025
Supplement: S004
Product code: OZA
Decision date: 2013-05-29
Classification: Test, Urea Adult And Pediatric (breath),
Generic name: Test, urea adult and pediatric (breath),
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.

Current openFDA PMA Record#

Device: BREATH TEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR
Applicant: Meridian Bioscience, Inc.
PMA number: P100025
Supplement: S004
Product code: OZA
Generic name: Test, urea adult and pediatric (breath),
Decision date: 2013-05-29
Decision code: APPR
Date received: 2013-02-01
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.