13C-SPIRULINA GEBT/13C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)

Gastric Emptying Breath Test

FDA Premarket Approval P110015 S002

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 of the qualification of additional service providers and the addition of a new test specification for the lyophilized egg (excipient) used in the production of the drug component of the 13c-spirulina gastric emptying breath test (gebt).

Device13C-SPIRULINA GEBT/13C-SPIRULINA GASTRIC EMPTYING BREATH TEST (GEBT)
Classification NameGastric Emptying Breath Test
Generic NameGastric Emptying Breath Test
ApplicantADVANCED BREATH DIAGNOSTICS
Date Received2016-07-15
Decision Date2017-01-06
PMAP110015
SupplementS002
Product CodePGE
Advisory CommitteeClinical Chemistry
Supplement Type135 Review Track For 30-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
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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