13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT

FDA Premarket Approval P110015 S010

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

Device13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT
Generic NameGastric Emptying Breath Test
ApplicantADVANCED BREATH DIAGNOSTICS105 Westpark Dr.suite 150brentwood, TN 37027 PMA NumberP110015 Supplement NumberS010 Date Received05/03/2022 Decision Date06/01/2022 Product Code PGE  Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-03
Decision Date2022-06-01
PMAP110015
SupplementS010
Product CodePGE 
Advisory CommitteeClinical Chemistry
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressADVANCED BREATH DIAGNOSTICS
105 Westpark Dr.
suite 150
brentwood, TN 37027 PMA NumberP110015 Supplement NumberS010 Date Received05/03/2022 Decision Date06/01/2022 Product Code PGE  Advisory Committee Clinical Chemistry Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
to Change The Quality Control Testing Of The 13C-Spirulina/Egg Mix. The 13C-Spirulina/Egg Mix Is A Component Of The 13C-Spirulina Gastric Emptying Breath Test (GEBT)

Supplemental Filings

Supplement NumberDateSupplement Type
P110015Original Filing
S010 2022-05-03 30-day Notice
S009
S008 2021-03-16 Real-time Process
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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