FDA Product Code
FDA Product Code KNK — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1775
510(k) Clearances — 118 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K102568 | URIC ACID MODEL 3P39 | Abbott Laboratories | 2011-05-06 | Traditional | PDF ↗ |
| K062862 | OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 | Olympus America, Inc. | 2007-04-06 | Traditional | PDF ↗ |
| K040467 | VITALAB URIC ACID REAGENT | Clinical Data, Inc. | 2004-03-08 | Traditional | PDF ↗ |
| K031044 | ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR | Clinical Data, Inc. | 2003-07-15 | Traditional | PDF ↗ |
| K022096 | URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2003-03-18 | Traditional | PDF ↗ |
| K023550 | WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA | Wiener Laboratories Saic | 2002-12-09 | Traditional | PDF ↗ |
| K012038 | JAS URIC ACID LIQUID REAGENT | Jas Diagnostics, Inc. | 2001-08-21 | Traditional | PDF ↗ |
| K010421 | WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X50 ML CATALOGUE NO 1840105 | Wiener Laboratories Saic | 2001-04-13 | Traditional | PDF ↗ |
| K993469 | WAKO L-TYPE UA F TEST | Wako Chemicals USA, Inc. | 1999-11-09 | Traditional | PDF ↗ |
| K991247 | URIC ACID, MODEL UA112-01 | A.P. Total Care, Inc. | 1999-05-25 | Traditional | PDF ↗ |
| K981604 | CARESIDE URIC ACID | Careside, Inc. | 1998-06-25 | Traditional | PDF ↗ |
| K970919 | SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT | Beckman Instruments, Inc. | 1997-05-21 | Traditional | PDF ↗ |
| K970867 | URIC ACID REAGENT | Derma Media Lab., Inc. | 1997-04-21 | Traditional | PDF ↗ |
| K971133 | URIC, UA, OR URIC ACID | Carolina Liquid Chemistries Corp. | 1997-04-14 | Traditional | PDF ↗ |
| K970560 | URIC ACID (LIQUID) REAGENT SET | Pointe Scientific, Inc., | 1997-03-11 | Traditional | PDF ↗ |
| K961586 | URIC ACID-SL ASSAY CATALOGUE NO. 237-60 | Diagnostic Chemicals , Ltd. | 1996-07-23 | Traditional | PDF ↗ |
| K955496 | URIC ACID CATALOGE# 220-93/94/97 | Diagnostic Chemicals , Ltd. | 1996-02-23 | Traditional | PDF ↗ |
| K943002 | URIC ACID QVET | Prisma Systems | 1994-12-02 | Traditional | PDF ↗ |
| K932728 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC) | Eastman Kodak Company | 1994-04-25 | Traditional | PDF ↗ |
| K931350 | IL TEST URIC ACID | Instrumentation Laboratory CO | 1993-10-01 | Traditional | PDF ↗ |
| K923503 | URIC ACID ENZYMATIC COLORIMERIC KIT | Randox Laboratories, Ltd. | 1993-07-22 | Traditional | PDF ↗ |
| K925113 | OLYMPUS URIC ACID REAGENT | Olympus Corp. | 1993-01-26 | Traditional | PDF ↗ |
| K923414 | SYNERMED 600 NM URIC ACID REAGENT KIT | Synermed, Inc. | 1992-09-22 | Traditional | PDF ↗ |
| K924129 | MILES AUTO METH DETERMIN OF URIC ACID IN URINE | Heraeus Kulzer, Inc. | 1992-09-22 | Traditional | PDF ↗ |
| K922756 | OLYMPUS URIC ACID REAGENT | Olympus Corp. | 1992-07-17 | Traditional | PDF ↗ |
| K922762 | ROCHE REAGENT FOR URIC ACID--MODIFICATION | Roche Diagnostic Systems, Inc. | 1992-07-09 | Traditional | PDF ↗ |
| K914158 | URIC ACID REAGENT SET | Tech Intl. Co. | 1992-02-21 | Traditional | PDF ↗ |
| K912028 | URIC ACID (URICASE) REAGENT, UNIVERSAL | Enzyme Technology, Inc. | 1991-12-18 | Traditional | PDF ↗ |
| K913706 | ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34 | Em Diagnostic Systems, Inc. | 1991-09-27 | Traditional | PDF ↗ |
| K903727 | SYNERMED URIC ACID REAGENT KIT | Synermed, Inc. | 1990-09-27 | Traditional | PDF ↗ |
| K896225 | COBAS READY PROFILE 2 REAGENT STRIP | Roche Diagnostic Systems, Inc. | 1990-06-26 | Traditional | PDF ↗ |
| K901001 | URIC ACID TEST KIT | Elite Technology, Inc. | 1990-05-23 | Traditional | PDF ↗ |
| K901544 | WAKO(TM) AUTOKIT URIC ACID | Wako Chemicals USA, Inc. | 1990-05-14 | Traditional | PDF ↗ |
| K901693 | TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC | Technicon Instruments Corp. | 1990-04-25 | Traditional | PDF ↗ |
| K897161 | COULTER URIC ACID REAGENT | Coulter Electronics, Inc. | 1990-03-01 | Traditional | PDF ↗ |
| K896954 | ABBOTT SPECTRUM URIC ACID REAGENT KIT | Abbott Laboratories | 1990-02-23 | Traditional | PDF ↗ |
| K896521 | MODIFIED PARAMAX URIC ACID REAGENT | Baxter Healthcare Corp | 1990-02-16 | Traditional | PDF ↗ |
| K896227 | COBAS READY URIC ACID REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-16 | Traditional | PDF ↗ |
| K895821 | URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS | Catachem, Inc. | 1989-12-05 | Traditional | PDF ↗ |
| K895665 | URIC ACID PAP | Boehringer Mannheim Corp. | 1989-10-23 | Traditional | PDF ↗ |
| K894101 | ROCHE REAGENT FOR URIC ACID | Roche Diagnostic Systems, Inc. | 1989-09-05 | Traditional | PDF ↗ |
| K894287 | URIC ACID TEST ITEM NUMBER 65422 | Em Diagnostic Systems, Inc. | 1989-08-28 | Traditional | PDF ↗ |
| K893416 | URIC ACID REAGENT (PROCEDURE NUMBER 686) | Sigma Chemical Co. | 1989-06-23 | Traditional | PDF ↗ |
| K892395 | AMRESCO URIC ACID REAGENTS #7628 | American Research Products Co. | 1989-05-24 | Traditional | PDF ↗ |
| K890319 | URIC ACID KIT, CODES 4825400 AND 4825050 | American Research Products Co. | 1989-04-12 | Traditional | PDF ↗ |
| K884704 | URIC ACID TEST (URIC) ITEM #65620 | Em Diagnostic Systems, Inc. | 1989-01-23 | Traditional | PDF ↗ |
| K883404 | URIC ACID REAGENT (PRODUCT #88219) | Hichem Diagnostics | 1988-09-13 | Traditional | PDF ↗ |
| K883428 | BIOTROL URIC ACID ENZYMATIQUE TRINDER | Biotrol, USA, Inc. | 1988-09-13 | Traditional | PDF ↗ |
| K880277 | URIC ACID REAGENT SET | Tech-Neal Scientific, Inc. | 1988-04-18 | Traditional | PDF ↗ |
| K880731 | WAKO AUTOKIT URIC ACID | Wako Chemicals USA, Inc. | 1988-03-24 | Traditional | PDF ↗ |
| K873456 | PARAMAX URIC ACID REAGENT | Baxter Healthcare Corp | 1987-11-23 | Traditional | PDF ↗ |
| K873363 | URIC ACID PAP | Boehringer Mannheim Corp. | 1987-10-19 | Traditional | PDF ↗ |
| K871892 | TECHNICON RA(R) SYSTEMS & ASSIST(R) CLIN. ANALYZER | Technicon Instruments Corp. | 1987-06-17 | Traditional | PDF ↗ |
| K871902 | THE URIC ACID REAGENT SET | Macomb Biotechnology, Inc. | 1987-06-03 | Traditional | PDF ↗ |
| K871417 | COLORIMETRIC URIC ACID REAGENT SET | Biochemical Trade, Inc. | 1987-04-22 | Traditional | PDF ↗ |
| K870868 | EASY-TEST URIC ACID (URIC) #16606 | Em Diagnostic Systems, Inc. | 1987-03-19 | Traditional | PDF ↗ |
| K870632 | FAST URIC ACID | Sclavo, Inc. | 1987-03-13 | Traditional | PDF ↗ |
| K864341 | IQ URIC ACID TEST | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1986-12-16 | Traditional | PDF ↗ |
| K863924 | URIC ACID | Tech-Co, Inc. | 1986-11-24 | Traditional | PDF ↗ |
| K864119 | URIC ACID TEST | U. S. Diagnostics, Inc. | 1986-10-29 | Traditional | PDF ↗ |
| K863251 | URIC ACID PROCEDURE | Data Medical Associates, Inc. | 1986-09-26 | Traditional | PDF ↗ |
| K863113 | URICMETER | J. D. Assoc. | 1986-09-09 | Traditional | PDF ↗ |
| K861831 | REFLOTRON URIC ACID | Boehringer Mannheim Corp. | 1986-07-11 | Traditional | PDF ↗ |
| K862208 | KING DIAGNOSTICS URIC ACID TEST | King Diagnostics, Inc. | 1986-07-08 | Traditional | PDF ↗ |
| K861660 | URIC ACID PROCEDURE | Data Medical Associates, Inc. | 1986-06-13 | Traditional | PDF ↗ |
| K860732 | ENZYMATIC URIC ACID REAGENT | Trace Scientific , Ltd. | 1986-04-16 | Traditional | PDF ↗ |
| K860916 | EASY-TEST URIC ACID (URIC), #67516/93 | Em Diagnostic Systems, Inc. | 1986-04-07 | Traditional | PDF ↗ |
| K860477 | URIC ACID REAGNET SET (TRINDER) | Sterling Diagnostics, Inc. | 1986-04-03 | Traditional | PDF ↗ |
| K854185 | IN-VITRO TEST DETERMINATION OF URIC ACID | Clinical Data, Inc. | 1985-11-25 | Traditional | PDF ↗ |
| K853825 | URIC ACID(URICASE) FOR CONTINUOUS FLOW INSTRUMENTS | Catachem, Inc. | 1985-09-30 | Traditional | PDF ↗ |
| K853357 | URIC ACID REAGENT | Sigma Diagnostics, Inc. | 1985-08-19 | Traditional | PDF ↗ |
| K852004 | UA(URICASE) REAGENT | Alpkem Corp. | 1985-05-29 | Traditional | PDF ↗ |
| K851991 | UN(UREASE)REAGENT UN(A-KETO)REAGENT | Alpkem Corp. | 1985-05-29 | Traditional | PDF ↗ |
| K843938 | LINEAR ENZYMATIC URIC ACID SYSTEM | Simmler, Inc. | 1984-10-30 | Traditional | PDF ↗ |
| K844011 | FOCUS URIC ACID | Abbott Laboratories | 1984-10-30 | Traditional | PDF ↗ |
| K843325 | SYSTEMATE URIC ACID, HEM 67220 | Em Diagnostic Systems, Inc. | 1984-09-13 | Traditional | PDF ↗ |
| K842442 | AXIOM STABLE II URIC ACID TEST | Axiom, Inc. | 1984-08-16 | Traditional | PDF ↗ |
| K842103 | TOYO JOZO URIC ACID TEST | Advocacy International, Ltd. | 1984-08-12 | Traditional | PDF ↗ |
| K842246 | URIC ACID ASSAY KIT | Diagnostic Chemicals, Ltd. (Usa) | 1984-07-18 | Traditional | PDF ↗ |
| K841702 | TDX REA URIC ACID | Abbott Laboratories | 1984-05-31 | Traditional | PDF ↗ |
| K841049 | URIC ACID REAGENT SET ENZYMATIC | Medical Specialties, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K840781 | URIC ACID REAGENT | American Dade | 1984-04-13 | Traditional | PDF ↗ |
| K834045 | URIC ACID REAGENT SET | Sterling Biochemical, Inc. | 1984-01-30 | Traditional | PDF ↗ |
| K832785 | COMPUR* EASY TOUCH URIC ACID REAGENT | Worthington Diagnostic Systems | 1983-10-14 | Traditional | PDF ↗ |
| K831983 | DATA-ZYME URIC ACID PROCEDURE | Data Medical Associates, Inc. | 1983-08-08 | Traditional | PDF ↗ |
| K831864 | URIC-ACID TEST ENZYMATIC COLORIMETRIC | Stanbio Laboratory | 1983-07-22 | Traditional | PDF ↗ |
| K831398 | LINEAR ENZMATIC URIC ACID SYSTEM | Simmler, Inc. | 1983-06-08 | Traditional | PDF ↗ |
| K830679 | URIC ACID COLORIMETRIC DETERMINATION | Dow Instruments & Reagents, Inc. | 1983-04-06 | Traditional | PDF ↗ |
| K823846 | URIC ACID TEST | Scalavo, Inc. | 1983-01-24 | Traditional | PDF ↗ |
| K822913 | URIC ACID REAGENT | Ac Biochemical Laboratories, Inc. | 1982-12-20 | Traditional | PDF ↗ |
| K821741 | URICACID | Biodynamics Corp. | 1982-07-02 | Traditional | PDF ↗ |
| K821812 | BECKMAN URIC ACID REAGENT | Beckman Instruments, Inc. | 1982-07-02 | Traditional | PDF ↗ |
| K821214 | URIC ACID REAGENT SET(ENZYMATIC | Omega Medical Electronics | 1982-05-21 | Traditional | PDF ↗ |
| K820632 | COLORIMETRIC URIC ACID REAGENT SET | Biorent Diagnostic, Inc. | 1982-03-25 | Traditional | PDF ↗ |
| K813511 | URIC-ACID | Medical Analysis Systems, Inc. | 1981-12-31 | Traditional | PDF ↗ |
| K812978 | URIC ACID SYSTEM PACK TEST | Boehringer Mannheim Corp. | 1981-11-06 | Traditional | PDF ↗ |
| K812700 | URICAR | Hi Chem, Inc. | 1981-11-05 | Traditional | PDF ↗ |
| K812641 | URIC ACID REAGENT-ENZYMATIC-COLOR-520 NM | Reagents Applications, Inc. | 1981-10-02 | Traditional | PDF ↗ |
| K812430 | URIC ACID REAGENT SET | Pointe Scientific, Inc., | 1981-09-09 | Traditional | PDF ↗ |
| K811810 | URIC ACID TEST | Environmental Chemical Specialties | 1981-07-15 | Traditional | PDF ↗ |
Product code KNK · Class I · Clinical Chemistry. Data: openFDA.