FDA.reportPublic FDA data

510(k) K083724

Device
WIENER LAB. URINE STRIP 10 AND 11
Applicant
WIENER LABORATORIOS S.A.I.C.
510(k) number
K083724
Product code
JIO  
Decision
Substantially Equivalent (SESE)
Decision date
2009-09-02
Date received
2008-12-15
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
VIVINA CETOLA
Address
2944 Riobamba Rosario, Santa Fe AR 2000 2000

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
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
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