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510(k) K923503

Device
URIC ACID ENZYMATIC COLORIMERIC KIT
Applicant
RANDOX LABORATORIES, LTD.
510(k) number
K923503
Product code
KNK  
Decision
Substantially Equivalent (SESE)
Decision date
1993-07-22
Date received
1992-07-15
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
John Lamont
Address
Ardmore, Diamond Rd. Crumlin, Bt29 4qy Co. Antrim, N. Ireland IR

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
K010421WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105Wiener Laboratories Saic2001-04-13
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

Legacy Summary#

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FDA Review#

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