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510(k) K232317

Device
UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent Strips
Applicant
Urit Medical Electronic Co., Ltd.
510(k) number
K232317
Product code
JIO
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-26
Date received
2023-08-03
Regulation
864.6550
Classification name
Blood, Occult, Colorimetric, In Urine
Medical specialty
Hematology
Review panel
Hematology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jiang Jun
Address
# D-07 Information Industry District, High-Tech Zone, Guilin, Guangxi 541004, P.R.China Guilin CN 541004 541004

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JIO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K111999HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINALHealgen Scientific,, LLC2012-04-17
K111221MISSION U500 URINE ANALYZERACON Laboratories, Inc.2012-01-18
K082811URITEST 10G & 11G URINE REAGENT STRIPS AND URITEST-50 AND URITEST-500B URINE ANALYZERSUrit Medical Electronic Co., Ltd.2009-09-11
K083724WIENER LAB. URINE STRIP 10 AND 11Wiener Laboratorios Saic2009-09-02
K040703URISTIK H SERIES REAGENT STRIPS FOR URINALYSISDirui Industrial Co., Ltd.2004-08-26
K023297URS-1B (BLOOD TEST)Teco Diagnostics2003-03-06
K921495DIA STRIPS SYSTEM, MODIFIEDSymcon Intl., Inc.1992-07-21
K913005BACTIDROP(TM) LACTOPHENOL ANILINE BLUERemel Co.1991-09-16
K905396HEMASTIX REAGENT STRIPSHeraeus Kulzer, Inc.1991-02-11
K893894CHARISE CHARLES REAGENT BLOOD STRIPSLee Import Domestic Consulting1989-07-27