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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Device13C-Spirulina Gastric Emptying Breath Test (GEBT)
Generic Namegastric emptying breath test
105 westpark dr.
suite 150
brentwood, TN 37027
PMA NumberP110015
Supplement NumberS006
Date Received10/30/2019
Decision Date11/25/2019
Product Code PGE 
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Qualification of water activity meter used to analyze solid samples for the 13C-Spirulina gastric emptying breath test (GEBT).