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KNK — Acid, Uric, Uricase (Colorimetric) Class I

FDA Device Classification

Classification Details

Product Code
KNK
Device Class
Class I
Regulation Number
862.1775
Submission Type
Review Panel
CH
Medical Specialty
Clinical Chemistry
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K102568abbott laboratoriesURIC ACID MODEL 3P39May 6, 2011
K062862olympus americaOLYMPUS URIC ACID REAGENT, MODEL OSR6X98April 6, 2007
K040467clinical dataVITALAB URIC ACID REAGENTMarch 8, 2004
K031044clinical dataATAC PAK URIC ACID REAGENT AND ATAC CALIBRATORJuly 15, 2003
K022096bayer diagnosticsURIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMMarch 18, 2003
K023550wiener laboratories saicWIENER LAB URICOSTAT ENZIMATICO AA LIQUIDADecember 9, 2002
K012038jas diagnosticsJAS URIC ACID LIQUID REAGENTAugust 21, 2001
K010421wiener laboratories saicWIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X5April 13, 2001
K993469wako chemicals usaWAKO L-TYPE UA F TESTNovember 9, 1999
K991247a.p. total careURIC ACID, MODEL UA112-01May 25, 1999
K981604caresideCARESIDE URIC ACIDJune 25, 1998
K970919beckman instrumentsSYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENTMay 21, 1997
K970867derma media labURIC ACID REAGENTApril 21, 1997
K971133carolina liquid chemistriesURIC, UA, OR URIC ACIDApril 14, 1997
K970560pointe scientific, incURIC ACID (LIQUID) REAGENT SETMarch 11, 1997
K961586diagnostic chemicalsURIC ACID-SL ASSAY CATALOGUE NO. 237-60July 23, 1996
K955496diagnostic chemicalsURIC ACID CATALOGE# 220-93/94/97February 23, 1996
K943002prisma systemsURIC ACID QVETDecember 2, 1994
K932728eastman kodakKODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC)April 25, 1994
K931350instrumentation laboratoryIL TEST URIC ACIDOctober 1, 1993