510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K063295Substantially Equivalent

Acon Uti Urinary Tract Infection Test Strips

Acon Laboratories, Inc., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063295 is the FDA 510(k) clearance record for ACON UTI URINARY TRACT INFECTION TEST STRIPS, a class I device, cleared for ACON Laboratories, Inc. on under FDA product code LJX (Test, Urine Leukocyte). FDA records list 93 510(k) clearances for ACON Laboratories, Inc., from to . As of , FDA records show no recalls naming K063295.

Clearance record

Decision date
Received
(345 days to decision)
Product code
LJX Test, Urine Leukocyte
Regulation
21 CFR 864.7675
Device class
Class I
Review panel
Hematology
Applicant
ACON Laboratories, Inc. 4108 Sorrento Valley Blvd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LJX

Trailing 12 months

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

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