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
K813056Substantially Equivalent

Automated Urinalysis System

Kyoto Daiichi Kagaku Co., Ltd., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K813056 is the FDA 510(k) clearance record for AUTOMATED URINALYSIS SYSTEM, a class I device, cleared for Kyoto Daiichi Kagaku Co., Ltd. on under FDA product code KQO (Automated Urinalysis System). FDA records list 3 510(k) clearances for Kyoto Daiichi Kagaku Co., Ltd., from to . As of , FDA records show no recalls naming K813056.

Clearance record

Decision date
Received
(188 days to decision)
Product code
KQO Automated Urinalysis System
Regulation
21 CFR 862.2900
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Kyoto Daiichi Kagaku Co., Ltd. 4221 Richmond Rd., NW, Walker MI
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