510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000373Substantially Equivalent

939Udx Urine Pathology System

Intl. Remote Imaging Systems, Chatsworth CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000373 is the FDA 510(k) clearance record for 939UDX URINE PATHOLOGY SYSTEM, a class II device, cleared for Intl. Remote Imaging Systems on under FDA product code LKM (Counter, Urine Particle). FDA records list 14 510(k) clearances for Intl. Remote Imaging Systems, from to . As of , FDA records show no recalls naming K000373.

Clearance record

Decision date
Received
(70 days to decision)
Product code
LKM Counter, Urine Particle
Regulation
21 CFR 864.5200
Device class
Class II
Review panel
Hematology
Applicant
Intl. Remote Imaging Systems 9162 Eton Ave., Chatsworth CA
510(k) summary
Summary
Third party review
No

Clearances, product code LKM

Trailing 12 months

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

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