|
Device | 13C-Spirulina Gastric Emptying Breath Test (GEBT) |
Generic Name | Gastric Emptying Breath Test |
Applicant | ADVANCED BREATH DIAGNOSTICS 105 WESTPARK DR. SUITE 150 BRENTWOOD, TN 37027 |
PMA Number | P110015 |
Supplement Number | S005 |
Date Received | 03/05/2019 |
Decision Date | 08/29/2019 |
Product Code |
PGE |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for changing the manufacturing site for the unit dose packaged 13C-Spirulina/egg mix that constitutes the diagnostic drug product in the Gastric Emptying Breath Test (GEBT). |