510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K000578Substantially Equivalent

Serim Leukocyte Esterase Test Strips

Serim Research Corp., Elkhart IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000578 is the FDA 510(k) clearance record for SERIM LEUKOCYTE ESTERASE TEST STRIPS, a class I device, cleared for Serim Research Corp. on under FDA product code LJX (Test, Urine Leukocyte). FDA records list 31 510(k) clearances for Serim Research Corp., from to . As of , FDA records show no recalls naming K000578.

Clearance record

Decision date
Received
(73 days to decision)
Product code
LJX Test, Urine Leukocyte
Regulation
21 CFR 864.7675
Device class
Class I
Review panel
Hematology
Applicant
Serim Research Corp. 23565 Reedy Dr., Elkhart IN
510(k) summary
Summary
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