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
K840829Substantially Equivalent

Kyotest Ugk

Kyoto Diagnostics, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K840829 is the FDA 510(k) clearance record for KYOTEST UGK, a class II device, cleared for Kyoto Diagnostics, Inc. on under FDA product code JIL (Method, Enzymatic, Glucose (Urinary, Non-Quantitative)). FDA records list 11 510(k) clearances for Kyoto Diagnostics, Inc., from to . As of , FDA records show no recalls naming K840829.

Clearance record

Decision date
Received
(55 days to decision)
Product code
JIL Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Regulation
21 CFR 862.1340
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Kyoto Diagnostics, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JIL

Trailing 12 months

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

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