510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K955629Substantially Equivalent

Lxn Fructosamine Test

Lxn Corp., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K955629 is the FDA 510(k) clearance record for LXN FRUCTOSAMINE TEST, a class I device, cleared for Lxn Corp. on under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)). FDA records list 7 510(k) clearances for Lxn Corp., from to . As of , FDA records show no recalls naming K955629.

Clearance record

Decision date
Received
(100 days to decision)
Product code
JJX Single (Specified) Analyte Controls (Assayed And Unassayed)
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Lxn Corp. 5830 Oberlin Dr., San Diego CA
510(k) summary
Statement
Third party review
No

Clearances, product code JJX

Trailing 12 months

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

FDA records show no clearances under product code JJX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JJX, 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