PMA P100025S011

Device: BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
Applicant: Meridian Bioscience, Inc.
PMA number: P100025
Supplement: S011
Product code: OZA
Decision date: 2017-01-04
Classification: Test, Urea Adult And Pediatric (breath),
Generic name: Test, urea adult and pediatric (breath),
Approval order statement: Change to the DMF for a raw material used to produce the finished drug component of the device.

Current openFDA PMA Record#

Device: BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0
Applicant: Meridian Bioscience, Inc.
PMA number: P100025
Supplement: S011
Product code: OZA
Generic name: Test, urea adult and pediatric (breath),
Decision date: 2017-01-04
Decision code: OK30
Date received: 2016-12-06
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change to the DMF for a raw material used to produce the finished drug component of the device.