510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093098Substantially Equivalent

Aution Max Model Ax-4030 Urinalysis System

Arkray, Inc., Richardson TX / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093098 is the FDA 510(k) clearance record for AUTION MAX MODEL AX-4030 URINALYSIS SYSTEM, a class I device, cleared for Arkray, Inc. on under FDA product code KQO (Automated Urinalysis System). FDA records list 18 510(k) clearances for Arkray, Inc., from to . As of , FDA records show no recalls naming K093098.

Clearance record

Decision date
Received
(83 days to decision)
Product code
KQO Automated Urinalysis System
Regulation
21 CFR 862.2900
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Arkray, Inc. 1201 Richardson Dr., Richardson TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KQO

Trailing 12 months

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

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