Lingo Glucose System— 510(k) K233655
Substantially EquivalentAbbott
FDA 510(k) clearance K233655 for Lingo Glucose System, Substantially Equivalent on 2024-05-29. Applicant: Abbott. Device class: 2.
Clearance details
- Applicant
- Abbott
- Product code
- Code SAF
- Device class
- Class 2
- Regulation
- 21 CFR 862.1355
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Alameda, CA, US
Recent devices under product code SAF
view allMore clearances from Abbott
view allAdverse events under product code SAF
product code SAF- Injury
- 164
- Malfunction
- 1,935
- Total
- 2,099
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.