13 C-Spirulina Gastric Emptying Breath Test (GEBT)

FDA Premarket Approval P110015 S007

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

Approval for changes to the quality control process used during the manufacture of the 13c-spirulina substrate. The substrate is a component of the gebt.

Device13 C-Spirulina Gastric Emptying Breath Test (GEBT)
Generic NameGastric Emptying Breath Test
ApplicantADVANCED BREATH DIAGNOSTICS
Date Received2021-02-23
Decision Date2021-03-16
PMAP110015
SupplementS007
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
S007 2021-02-23 30-day Notice
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
S003
S002 2016-07-15 135 Review Track For 30-day Notice
S001

NIH GUDID Devices

Device IDPMASupp
M763K0211 P110015 000

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