Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KNK — Predicate Candidate Screening
118 FDA 510(k) clearances under this product code; the 50 most recent screened below.
42 daysmedian FDA review time
109 days90th percentile
118clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K102568 | URIC ACID MODEL 3P39 | Abbott Laboratories | 2011-05-06 | 241 | 0 |
| K062862 | OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 | Olympus America, Inc. | 2007-04-06 | 193 | 1 |
| K040467 | VITALAB URIC ACID REAGENT | Clinical Data, Inc. | 2004-03-08 | 13 | 0 |
| K031044 | ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR | Clinical Data, Inc. | 2003-07-15 | 105 | 0 |
| K022096 | URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2003-03-18 | 264 | 0 |
| K023550 | WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA | Wiener Laboratories Saic | 2002-12-09 | 48 | 0 |
| K012038 | JAS URIC ACID LIQUID REAGENT | Jas Diagnostics, Inc. | 2001-08-21 | 53 | 0 |
| K010421 | WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGU | Wiener Laboratories Saic | 2001-04-13 | 60 | 0 |
| K993469 | WAKO L-TYPE UA F TEST | Wako Chemicals USA, Inc. | 1999-11-09 | 27 | 0 |
| K991247 | URIC ACID, MODEL UA112-01 | A.P. Total Care, Inc. | 1999-05-25 | 43 | 0 |
| K981604 | CARESIDE URIC ACID | Careside, Inc. | 1998-06-25 | 58 | 0 |
| K970919 | SYNCHRON CX SYSTEMS URIC ACID (URIC) REAGENT | Beckman Instruments, Inc. | 1997-05-21 | 70 | 0 |
| K970867 | URIC ACID REAGENT | Derma Media Lab., Inc. | 1997-04-21 | 42 | 0 |
| K971133 | URIC, UA, OR URIC ACID | Carolina Liquid Chemistries Corp. | 1997-04-14 | 18 | 0 |
| K970560 | URIC ACID (LIQUID) REAGENT SET | Pointe Scientific, Inc., | 1997-03-11 | 26 | 2 |
| K961586 | URIC ACID-SL ASSAY CATALOGUE NO. 237-60 | Diagnostic Chemicals , Ltd. | 1996-07-23 | 90 | 0 |
| K955496 | URIC ACID CATALOGE# 220-93/94/97 | Diagnostic Chemicals , Ltd. | 1996-02-23 | 84 | 0 |
| K943002 | URIC ACID QVET | Prisma Systems | 1994-12-02 | 162 | 0 |
| K932728 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (URIC) | Eastman Kodak Company | 1994-04-25 | 322 | 0 |
| K931350 | IL TEST URIC ACID | Instrumentation Laboratory CO | 1993-10-01 | 198 | 0 |
| K923503 | URIC ACID ENZYMATIC COLORIMERIC KIT | Randox Laboratories, Ltd. | 1993-07-22 | 372 | 0 |
| K925113 | OLYMPUS URIC ACID REAGENT | Olympus Corp. | 1993-01-26 | 109 | 0 |
| K924129 | MILES AUTO METH DETERMIN OF URIC ACID IN URINE | Heraeus Kulzer, Inc. | 1992-09-22 | 36 | 0 |
| K923414 | SYNERMED 600 NM URIC ACID REAGENT KIT | Synermed, Inc. | 1992-09-22 | 74 | 0 |
| K922756 | OLYMPUS URIC ACID REAGENT | Olympus Corp. | 1992-07-17 | 38 | 0 |
| K922762 | ROCHE REAGENT FOR URIC ACID--MODIFICATION | Roche Diagnostic Systems, Inc. | 1992-07-09 | 51 | 0 |
| K914158 | URIC ACID REAGENT SET | Tech Intl. Co. | 1992-02-21 | 157 | 0 |
| K912028 | URIC ACID (URICASE) REAGENT, UNIVERSAL | Enzyme Technology, Inc. | 1991-12-18 | 224 | 0 |
| K913706 | ABBOTT QUICKSTART URIC ACID TEST (URCA) ITEM# 5A34 | Em Diagnostic Systems, Inc. | 1991-09-27 | 39 | 0 |
| K903727 | SYNERMED URIC ACID REAGENT KIT | Synermed, Inc. | 1990-09-27 | 42 | 0 |
| K896225 | COBAS READY PROFILE 2 REAGENT STRIP | Roche Diagnostic Systems, Inc. | 1990-06-26 | 239 | 0 |
| K901001 | URIC ACID TEST KIT | Elite Technology, Inc. | 1990-05-23 | 82 | 0 |
| K901544 | WAKO(TM) AUTOKIT URIC ACID | Wako Chemicals USA, Inc. | 1990-05-14 | 41 | 0 |
| K901693 | TECHNICON CHEM 1 CLINICAL ANALYZER FOR URINE URIC | Technicon Instruments Corp. | 1990-04-25 | 14 | 0 |
| K897161 | COULTER URIC ACID REAGENT | Coulter Electronics, Inc. | 1990-03-01 | 63 | 0 |
| K896954 | ABBOTT SPECTRUM URIC ACID REAGENT KIT | Abbott Laboratories | 1990-02-23 | 71 | 0 |
| K896227 | COBAS READY URIC ACID REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-16 | 109 | 0 |
| K896521 | MODIFIED PARAMAX URIC ACID REAGENT | Baxter Healthcare Corp | 1990-02-16 | 93 | 0 |
| K895821 | URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS | Catachem, Inc. | 1989-12-05 | 67 | 0 |
| K895665 | URIC ACID PAP | Boehringer Mannheim Corp. | 1989-10-23 | 33 | 0 |
| K894101 | ROCHE REAGENT FOR URIC ACID | Roche Diagnostic Systems, Inc. | 1989-09-05 | 88 | 0 |
| K894287 | URIC ACID TEST ITEM NUMBER 65422 | Em Diagnostic Systems, Inc. | 1989-08-28 | 66 | 0 |
| K893416 | URIC ACID REAGENT (PROCEDURE NUMBER 686) | Sigma Chemical Co. | 1989-06-23 | 52 | 0 |
| K892395 | AMRESCO URIC ACID REAGENTS #7628 | American Research Products Co. | 1989-05-24 | 47 | 0 |
| K890319 | URIC ACID KIT, CODES 4825400 AND 4825050 | American Research Products Co. | 1989-04-12 | 79 | 0 |
| K884704 | URIC ACID TEST (URIC) ITEM #65620 | Em Diagnostic Systems, Inc. | 1989-01-23 | 75 | 0 |
| K883404 | URIC ACID REAGENT (PRODUCT #88219) | Hichem Diagnostics | 1988-09-13 | 33 | 0 |
| K883428 | BIOTROL URIC ACID ENZYMATIQUE TRINDER | Biotrol, USA, Inc. | 1988-09-13 | 29 | 0 |
| K880277 | URIC ACID REAGENT SET | Tech-Neal Scientific, Inc. | 1988-04-18 | 88 | 0 |
| K880731 | WAKO AUTOKIT URIC ACID | Wako Chemicals USA, Inc. | 1988-03-24 | 29 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda