PMA P100025S003

Device: BREATHTEK UBT FOR H. PYLORI HIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE APPLICATION (PUHR-CA)
Applicant: Meridian Bioscience, Inc.
PMA number: P100025
Supplement: S003
Product code: OZA
Decision date: 2012-11-06
Classification: Test, Urea Adult And Pediatric (breath),
Generic name: Test, urea adult and pediatric (breath),
Approval order statement: APPROVAL FOR A LABELING CHANGE TO ENHANCE THE SAFE USE OF THE DEVICE.

Current openFDA PMA Record#

Device: BREATHTEK UBT FOR H. PYLORI HIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE APPLICATION (PUHR-CA)
Applicant: Meridian Bioscience, Inc.
PMA number: P100025
Supplement: S003
Product code: OZA
Generic name: Test, urea adult and pediatric (breath),
Decision date: 2012-11-06
Decision code: APPR
Date received: 2012-10-12
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR A LABELING CHANGE TO ENHANCE THE SAFE USE OF THE DEVICE.