Atlas FDA

CDO

31 FDA 510(k) clearances · Product code

34 daysmedian time to decision
66 days90th percentile
31clearances measured

FDA profile

Official device name
Acid, Uric, Uricase (U.V.)
Device class
Class I (low risk)
Regulation
21 CFR 862.1775
Medical specialty
Clinical Chemistry
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RecordFirmDate
RANDOX URIC ACID (K033278)Randox Laboratories, Ltd.2004-02-27
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT, MODELS 684-25, 684-100P, 684-500P, 684-2000P, 683-20, 683-100P (K992798)Sigma Diagnostics, Inc.1999-09-28
SIGMA DIAGNOSTICS INFINITY URIC ACID REAGENT KIT (K982251)Sigma Diagnostics, Inc.1998-08-18
URIC ACID (K981766)Abbott Laboratories1998-06-19
URIC ACID (K981189)Abbott Laboratories1998-05-07
URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (K971485)Trace America, Inc.1997-05-27
OLYMPUS URIC ACID REAGENT (K955752)Olympus America, Inc.1996-01-31
URIC ACID TEST ITEM NUMBER 65422 (K932162)Em Diagnostic Systems, Inc.1993-09-27
SYSTEMATE URICACID TEST, TECHNICON RA 1000 (K923765)Em Diagnostic Systems, Inc.1992-09-22
SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422 (K903335)Em Diagnostic Systems, Inc.1990-08-17
BIOTROL URIC ACID ENZYMATIQUE UV H.P. (K875320)Biotrol, USA, Inc.1988-02-01
GEMENI URIC ACID U.V. (K873358)Electro-Nucleonics Laboratories, Inc.1987-09-11
EMDS URIC ACID (URC A) TESTPACK, ITEM #67664/95 (K863660)Em Diagnostic Systems, Inc.1986-10-29
ROCHE REAGENTS REAGENT FOR URIC ACID (K844986)Roche Diagnostic Systems, Inc.1985-01-18
URIC ACID 75CDO (K822884)Technicon Instruments Corp.1982-10-27
ULTRACHEM URIC ACID AIDH (K821872)Harleco Diagnostics1982-07-14
ULTRACHEM URIC ACID AIDH #65047 (K821474)Emd Chemicals, Inc.1982-06-03
ULTRACHEM URIC ACID AIDH, #65047 (K821465)Emd Chemicals, Inc.1982-06-02
URICASE (U.V.) URIC ACID (K821167)Syn-Kit, Inc.1982-05-14
UV URIC ACID DETERMINATION (K813244)Biorent Diagnostic, Inc.1981-12-08
ULTRACHEM URIC ACID ALDH, ITEM #65047 (K812500)Harleco1981-09-23
URIC ACID/ALDH (K802371)Boehringer Mannheim Corp.1980-10-23
COBAS REAGENTS FOR URIC ACID (K801243)Roche Analytical Instruments, Inc.1980-06-26
CENTRIFICHEM URIC ACID (K800130)Union Carbide Corp.1980-02-13
UV URIC ACID DETERMINATION (K790834)The Dow Chemical Co.1979-06-28
ACID REAGENT, URIC SINGLE VIAL (K781996)Calbiochem-Behring Corp.1979-01-03
PRINCETON BIOMEDIX URICASE (UV) (K780859)Bd Becton Dickinson Vacutainer Systems Preanalytic1978-07-27
MULTISTAT III URIC ACID TEST (K771509)Instrumentation Laboratory CO1977-09-13
STATZYME URIC ACID REAGENT (K770831)Worthington Biochemical Corp.1977-07-11
IN VITRO DIAG. FOR URIC ACID (K770767)Smithkline Diagnostics, Inc.1977-07-05
URIC ACID REAGENT SET (K760989)Worthington Biochemical Corp.1976-12-09

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