Product code KNK
- Device name
- Acid, Uric, Uricase (Colorimetric)
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1775
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K102568 | URIC ACID MODEL 3P39 | Abbott Laboratories | 2011-05-06 |
| K062862 | OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 | Olympus America, Inc. | 2007-04-06 |
| K040467 | VITALAB URIC ACID REAGENT | Clinical Data, Inc. | 2004-03-08 |
| K031044 | ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR | Clinical Data, Inc. | 2003-07-15 |
| K022096 | URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2003-03-18 |
| K023550 | WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA | Wiener Laboratories Saic | 2002-12-09 |
| K012038 | JAS URIC ACID LIQUID REAGENT | Jas Diagnostics, Inc. | 2001-08-21 |
| K010421 | WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 | Wiener Laboratories Saic | 2001-04-13 |
| K993469 | WAKO L-TYPE UA F TEST | Wako Chemicals USA, Inc. | 1999-11-09 |
| K991247 | URIC ACID, MODEL UA112-01 | A.P. Total Care, Inc. | 1999-05-25 |
| K981604 | CARESIDE URIC ACID | Careside, Inc. | 1998-06-25 |
| K970919 | SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT | Beckman Instruments, Inc. | 1997-05-21 |
| K970867 | URIC ACID REAGENT | Derma Media Lab., Inc. | 1997-04-21 |
| K971133 | URIC, UA, OR URIC ACID | Carolina Liquid Chemistries Corp. | 1997-04-14 |
| K970560 | URIC ACID (LIQUID) REAGENT SET | Pointe Scientific, Inc., | 1997-03-11 |
| K961586 | URIC ACID-SL ASSAY CATALOGUE NO. 237-60 | Diagnostic Chemicals , Ltd. | 1996-07-23 |
| K955496 | URIC ACID CATALOGE# 220-93/94/97 | Diagnostic Chemicals , Ltd. | 1996-02-23 |
| K943002 | URIC ACID QVET | Prisma Systems | 1994-12-02 |
| K932728 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC) | Eastman Kodak Company | 1994-04-25 |
| K931350 | IL TEST URIC ACID | Instrumentation Laboratory CO | 1993-10-01 |
| K923503 | URIC ACID ENZYMATIC COLORIMERIC KIT | Randox Laboratories, Ltd. | 1993-07-22 |
| K925113 | OLYMPUS URIC ACID REAGENT | Olympus Corp. | 1993-01-26 |
| K923414 | SYNERMED 600 NM URIC ACID REAGENT KIT | Synermed, Inc. | 1992-09-22 |
| K924129 | MILES AUTO METH DETERMIN OF URIC ACID IN URINE | Heraeus Kulzer, Inc. | 1992-09-22 |
| K922756 | OLYMPUS URIC ACID REAGENT | Olympus Corp. | 1992-07-17 |
| K922762 | ROCHE REAGENT FOR URIC ACID--MODIFICATION | Roche Diagnostic Systems, Inc. | 1992-07-09 |
| K914158 | URIC ACID REAGENT SET | Tech Intl. Co. | 1992-02-21 |
| K912028 | URIC ACID (URICASE) REAGENT, UNIVERSAL | Enzyme Technology, Inc. | 1991-12-18 |
| K913706 | ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34 | Em Diagnostic Systems, Inc. | 1991-09-27 |
| K903727 | SYNERMED URIC ACID REAGENT KIT | Synermed, Inc. | 1990-09-27 |
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|---|---|---|---|
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| 08806141304036 | ONE+Step Uric Acid | DFI CO.,LTD | 2025-09-03 |
| 08806141304029 | ONE+Step Uric Acid | DFI CO.,LTD | 2025-08-22 |
| 00850053916168 | IDG/Sanzay | IDG/SANZAY Corporation | 2024-01-12 |
| 10673486002263 | Teco Diagnostics Uric Acid Liquid Reagent Set | TECO DIAGNOSTICS | 2023-11-30 |
| 10673486002355 | Teco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-480 | TECO DIAGNOSTICS | 2023-11-15 |
| 10673486002348 | Teco Diagnostics Uric Acid Liquid Reagent Set | TECO DIAGNOSTICS | 2023-11-15 |
| 10673486002331 | Teco Diagnostics Uric Acid Liquid Reagent Kit TC-Matrix-240 | TECO DIAGNOSTICS | 2023-11-15 |
| 10673486002324 | Teco Diagnostics Uric Acid Liquid Reagent Set | TECO DIAGNOSTICS | 2023-11-15 |
| 10673486002317 | Teco Diagnostics Uric Acid Reagent Set | TECO DIAGNOSTICS | 2023-11-15 |
| 10673486002300 | Teco Diagnostics Uric Acid Reagent Set | TECO DIAGNOSTICS | 2023-11-15 |
| 06971674863908 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-14 |
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| 06971674863977 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-14 |
| 06971674864011 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-14 |
| 06971674864073 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-13 |
| 06971674864066 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-13 |
| 06971674864059 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-13 |
| 06971674864035 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-13 |
| 06971674864004 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-13 |
| 06971674863991 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-13 |
| 06971674863984 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-13 |
| 06971674863953 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-13 |
| 06971674863939 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-13 |
| 06971674863922 | BIOBASE | Biobase Biodustry(Shandong)Co., Ltd. | 2023-07-13 |
| EABA40000351 | Piccolo BioChemistry Panel Plus | ABAXIS, INC. | 2016-09-23 |
| EABA40000291 | Piccolo General Chemistry 13 | ABAXIS, INC. | 2016-09-23 |