510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K111874Substantially Equivalent

Freestyle Insulinx Blood Glucose Monitoring Systems

Abbott Medical, Alameda CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111874 is the FDA 510(k) clearance record for FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS, a class II device, cleared for Abbott Laboratories on under FDA product code LFR (Glucose Dehydrogenase, Glucose). FDA records list 1,478 510(k) clearances for Abbott Medical, from to . As of , FDA records show no recalls naming K111874.

Clearance record

Decision date
Received
(230 days to decision)
Product code
LFR Glucose Dehydrogenase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Abbott Laboratories 1360 S. Loop Rd., Alameda CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LFR

Trailing 12 months

FDA records hold no clearances under product code LFR in the trailing twelve months.

FDA records show no clearances under product code LFR in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LFR, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260