Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Establishment Registration & Device Listing
  • Print
  • Share
  • E-mail
-
New Search Back To Search Results
Proprietary Name: FreeStyle Libre 2 Flash Glucose Monitoring System; FreeStyle Libre 3 Continuous Glucose Monitoring System; Instinct sensor
Classification Name: INTEGRATED CONTINUOUS GLUCOSE MONITORING SYSTEM, FACTORY CALIBRATED, NOT FOR USE WITH AUTOMATED INSULIN DELIVERY SYSTEMS
Product Code: QLG
Device Class: 2
Regulation Number: 862.1355
Medical Specialty: Clinical Chemistry
Registered Establishment Name: ABBOTT DIABETES CARE INC.
Registered Establishment Number: 2954323
Premarket Submission Number: K233537
Owner/Operator: ABBOTT LABORATORIES
Owner/Operator Number: 1415939
Establishment Operations: Manufacturer; Specification Developer; Complaint File Establishment
-
-