FDA.reportPublic FDA data

510(k) K010421

Device
WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105
Applicant
WIENER LABORATORIES S.A.I.C.
510(k) number
K010421
Product code
KNK  
Decision
Substantially Equivalent (SESE)
Decision date
2001-04-13
Date received
2001-02-12
Regulation
862.1775
Classification name
Acid, Uric, Uricase (colorimetric)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
VIVIANA 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 KNK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K102568URIC ACID MODEL 3P39Abbott Laboratories2011-05-06
K062862OLYMPUS URIC ACID REAGENT, MODEL OSR6X98Olympus America, Inc.2007-04-06
K040467VITALAB URIC ACID REAGENTClinical Data, Inc.2004-03-08
K031044ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATORClinical Data, Inc.2003-07-15
K022096URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.2003-03-18
K023550WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDAWiener Laboratories Saic2002-12-09
K012038JAS URIC ACID LIQUID REAGENTJas Diagnostics, Inc.2001-08-21
K993469WAKO L-TYPE UA F TESTWako Chemicals USA, Inc.1999-11-09
K991247URIC ACID, MODEL UA112-01A.P. Total Care, Inc.1999-05-25
K981604CARESIDE URIC ACIDCareside, Inc.1998-06-25
K970919SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENTBeckman Instruments, Inc.1997-05-21
K970867URIC ACID REAGENTDerma Media Lab., Inc.1997-04-21
K971133URIC, UA, OR URIC ACIDCarolina Liquid Chemistries Corp.1997-04-14
K970560URIC ACID (LIQUID) REAGENT SETPointe Scientific, Inc.,1997-03-11
K961586URIC ACID-SL ASSAY CATALOGUE NO. 237-60Diagnostic Chemicals , Ltd.1996-07-23

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases