510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN250049Unknown

Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System

Abbott Diabetes Care, Alameda CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN250049 is the FDA 510(k) clearance record for Libre Duo 10 Day Continuous Dual Glucose Ketone Monitoring System, cleared for Abbott Diabetes Care on under FDA product code SJD. As of , FDA records show no recalls naming DEN250049.

Clearance record

Decision date
Received
(330 days to decision)
Product code
SJD Integrated Continuous Glucose Ketone Monitoring System
Regulation
21 CFR 862.1354
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Abbott Diabetes Care 1360 S. Loop Rd., Alameda CA
Third party review
No

Clearances, product code SJD

Trailing 12 months
1 clearance under product code SJD in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code SJD, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260