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
K102188Substantially Equivalent

Cybow Reader, Models 300 & 720

DFI Co., Ltd., Gangnam-Gu, Seoul, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102188 is the FDA 510(k) clearance record for CYBOW READER, MODELS 300 & 720, a class I device, cleared for DFI Co., Ltd. on under FDA product code KQO (Automated Urinalysis System). FDA records list one 510(k) clearance for DFI Co., Ltd. As of , FDA records show no recalls naming K102188.

Clearance record

Decision date
Received
(371 days to decision)
Product code
KQO Automated Urinalysis System
Regulation
21 CFR 862.2900
Device class
Class I
Review panel
Clinical Chemistry
Applicant
DFI Co., Ltd. #821 Samil Plz., 837-26, Gangnam-Gu, Seoul, KR
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