13C-Spirulina Gastric Emptying Breath Test (GEBT)

Gastric Emptying Breath Test

FDA Premarket Approval P110015 S006

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.

Pre-market Approval Supplement Details

Qualification of water activity meter used to analyze solid samples for the 13c-spirulina gastric emptying breath test (gebt)

Device13C-Spirulina Gastric Emptying Breath Test (GEBT)
Classification NameGastric Emptying Breath Test
Generic NameGastric Emptying Breath Test
Date Received2019-10-30
Decision Date2019-11-25
Product CodePGE
Advisory CommitteeClinical Chemistry
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address ADVANCED BREATH DIAGNOSTICS 105 Westpark Dr. suite 150 brentwood, TN 37027

Supplemental Filings

Supplement NumberDateSupplement Type
P110015Original Filing
S006 2019-10-30 30-day Notice
S005 2019-03-05 135 Review Track For 30-day Notice
S004 2018-06-14 30-day Notice
S002 2016-07-15 135 Review Track For 30-day Notice

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