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CDO — Acid, Uric, Uricase (U.V.) Class I

FDA Device Classification

Classification Details

Product Code
CDO
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
K033278randox laboratoriesRANDOX URIC ACIDFebruary 27, 2004
K992798sigma diagnosticsSIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P,September 28, 1999
K982251sigma diagnosticsSIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KITAugust 18, 1998
K981766abbott laboratoriesURIC ACIDJune 19, 1998
K981189abbott laboratoriesURIC ACIDMay 7, 1998
K971485trace americaURIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)May 27, 1997
K955752olympus americaOLYMPUS URIC ACID REAGENTJanuary 31, 1996
K932162em diagnostic systemsURIC ACID TEST ITEM NUMBER 65422September 27, 1993
K923765em diagnostic systemsSYSTEMATE URICACID TEST, TECHNICON RA 1000September 22, 1992
K903335em diagnostic systemsSYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422August 17, 1990
K875320biotrol, usaBIOTROL URIC ACID ENZYMATIQUE UV H.P.February 1, 1988
K873358electro-nucleonics laboratoriesGEMENI URIC ACID U.V.September 11, 1987
K863660em diagnostic systemsEMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95October 29, 1986
K844986roche diagnostic systemsROCHE REAGENTS REAGENT FOR URIC ACIDJanuary 18, 1985
K822884technicon instrumentsURIC ACID 75CDOOctober 27, 1982
K821872harleco diagnosticsULTRACHEM URIC ACID AIDHJuly 14, 1982
K821474emd chemicalsULTRACHEM URIC ACID AIDH #65047June 3, 1982
K821465emd chemicalsULTRACHEM URIC ACID AIDH, #65047June 2, 1982
K821167syn-kitURICASE (U.V.) URIC ACIDMay 14, 1982
K813244biorent diagnosticUV URIC ACID DETERMINATIONDecember 8, 1981