510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K152328Substantially Equivalent

FreeStyle InsuLinx Blood Glucose Monotioring System

Abott Laboratories, Alameda CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K152328 is the FDA 510(k) clearance record for FreeStyle InsuLinx Blood Glucose Monotioring System, a class II device, cleared for Abott Laboratories on under FDA product code LFR (Glucose Dehydrogenase, Glucose). FDA records list one 510(k) clearance for Abott Laboratories. As of , FDA records show no recalls naming K152328.

Clearance record

Decision date
Received
(30 days to decision)
Product code
LFR Glucose Dehydrogenase, Glucose
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Abott 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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LFR, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260