PMA P100025S001

Device: BREATH TEK UBTFOR H. PYLORI KIT
Applicant: Meridian Bioscience, Inc.
PMA number: P100025
Supplement: S001
Product code: OZA
Decision date: 2012-09-05
Classification: Test, Urea Adult And Pediatric (breath),
Generic name: Test, urea adult and pediatric (breath),
Approval order statement: APPROVAL FOR PACKAGING CHANGES FOR THE BREATHTEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0. THE PACKAGING CHANGES CONSIST OF NEW KIT AND SHIPPER CARTONS ALONG WITH NEW LABELING ON THE EACH OF THESE CARTONS.

Current openFDA PMA Record#

Device: BREATH TEK UBTFOR H. PYLORI KIT
Applicant: Meridian Bioscience, Inc.
PMA number: P100025
Supplement: S001
Product code: OZA
Generic name: Test, urea adult and pediatric (breath),
Decision date: 2012-09-05
Decision code: APPR
Date received: 2012-03-19
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR PACKAGING CHANGES FOR THE BREATHTEK UBT FOR H. PYLORI KIT (BREATHTEK UBT KIT) AND PEDIATRIC UREA HYDROLYSIS RATE CALCULATION APPLICATION (PUHR-CA), VERSION 1.0. THE PACKAGING CHANGES CONSIST OF NEW KIT AND SHIPPER CARTONS ALONG WITH NEW LABELING ON THE EACH OF THESE CARTONS.