PMA P100025S006

Device: BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)
Applicant: Meridian Bioscience, Inc.
PMA number: P100025
Supplement: S006
Product code: OZA
Decision date: 2014-02-19
Classification: Test, Urea Adult And Pediatric (breath),
Generic name: Test, urea adult and pediatric (breath),
Approval order statement: APPROVAL FOR THE CHANGES TO THE RELEASING SPECIFICATION FOR 13C-UREA TO COMPLY WITH THE USP MONOGRAPH CHANGES.

Current openFDA PMA Record#

Device: BREATHTEK UBT FOR H. PYLORI KIT AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA)
Applicant: Meridian Bioscience, Inc.
PMA number: P100025
Supplement: S006
Product code: OZA
Generic name: Test, urea adult and pediatric (breath),
Decision date: 2014-02-19
Decision code: APPR
Date received: 2014-01-22
Supplement type: Special (Immediate Track)
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE CHANGES TO THE RELEASING SPECIFICATION FOR 13C-UREA TO COMPLY WITH THE USP MONOGRAPH CHANGES.