510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K231045Substantially Equivalent

Healgen URS Test Strips

Healgen Scientific LLC, Bellaire TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K231045 is the FDA 510(k) clearance record for Healgen URS Test Strips, a class I device, cleared for Healgen Scientific,, LLC on under FDA product code LJX (Test, Urine Leukocyte). FDA records list 27 510(k) clearances for Healgen Scientific,, LLC, from to . As of , FDA records show no recalls naming K231045.

Clearance record

Decision date
Received
(65 days to decision)
Product code
LJX Test, Urine Leukocyte
Regulation
21 CFR 864.7675
Device class
Class I
Review panel
Hematology
Applicant
Healgen Scientific,, LLC 5213 Maple St., Bellaire TX
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