System, Breath Measurement
Clinical Chemistry · 21 CFR 862.1820
Breath measurement systems are used to measure constituents of exhaled breath as an aid in the diagnosis of sugar/nutrient malabsorbtion and other conditions.
Recent MDR events
0 adverse event reports on file
No MDR events on file for this product code.
Event type breakdown
No data available.
Most-reported manufacturers
No data available.
Recalls
3 recall events for this product code
- GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Lactose Intolerance Test
Distribution without premarket approval/clearance.
Z-0786-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
SIBO Test
Distribution without premarket approval/clearance.
Z-0796-2026 · View FDA record ↗ - GET TESTED INTERNATIONAL ABOpen, ClassifiedDec 1, 2025
Sorbitol Intolerance Test
Distribution without premarket approval/clearance.
Z-0797-2026 · View FDA record ↗
Registered firms
12 firms currently registered for this product code
Owlstone Medical Ltd
Cambridge Cambridgeshire, GB
Sentech Gmi Corp
Seoul, KR
Quintron Instrument Co. Inc.
New Berlin, WI, US
Alacer Industria Eletronica Ltda
Sao Paulo, BR
Foodmarble Digestive Health Limited
Dublin 8, IE
Qi Diagnostics Limited
Mongkok Hong Kong, CN
Md Diagnostics Ltd
Chatham Kent, GB
Zhejiang Mediunion Healthcare Group Co.,ltd
Ningbo Zhejiang, CN
Huwant Corp.
Daegu, KR
Bedfont Scientific Ltd.
MAIDSTONE Kent, GB
Mainline Medical Dental Supply
North York Ontario, CA
Rayco Electronic Ltd.
Dong Guan City Guangdong, CN
510(k) clearances
4 clearances for this product code