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510(k) K111999

Device
HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL
Applicant
HEALGEN SCIENTIFIC, LLC
510(k) number
K111999
Product code
JIO  
Decision
Substantially Equivalent (SESE)
Decision date
2012-04-17
Date received
2011-07-13
Regulation
864.6550
Classification name
Blood, Occult, Colorimetric, In Urine
Medical specialty
Hematology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
YONGQUAN WANG
Address
5213 Maple St. Bellaire TX US 77401 77401

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
K232317UC-1800 Automatic Urine Analyzer, URIT 11FA Urine Reagent Strips, URIT 12FA Urine Reagent StripsUrit Medical Electronic Co., Ltd.2024-04-26
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

Legacy Summary#

summary

FDA Review#

Decision Summary