Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
DCK · Predicate Candidate Screening
126 FDA 510(k) clearances under this product code; the 50 most recent screened below.
63 daysmedian FDA review time
187 days90th percentile
126clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242170 | K-ASSAY CRP (Ver.2) | Kamiya Biomedical Company, LLC | 2025-04-18 | 268 | 0 |
| K201256 | Procise CRP, ProciseDx Analyzer, ProciseDx Calibration Cartr | Procise Diagnostics | 2022-11-04 | 907 | 0 |
| K192028 | Yumizen C1200 CRP | HORIBA ABX SAS | 2020-06-25 | 335 | 0 |
| K192118 | CRP Vario | SENTINEL CH. SpA | 2019-11-08 | 94 | 0 |
| K191993 | Yumizen C1200 CRP | HORIBA ABX SAS | 2019-10-03 | 70 | 0 |
| K160712 | VITROS Chemistry Products hsCRP Reagent | Ortho Clinical Diagnostics | 2017-07-14 | 486 | 0 |
| K142993 | QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead | Orion Diagnostica, OY | 2016-03-10 | 511 | 0 |
| K152433 | VITROS Chemistry Products CRP Slides; VITRO Chemistry Produc | Ortho Clinical Diagnostics | 2015-09-24 | 28 | 2 |
| K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, Hi | Qualigen, Inc. | 2015-01-07 | 198 | 0 |
| K121558 | DIAZYME HSCRP POC TEST KIT | Diazyme Laboratories | 2012-09-21 | 115 | 0 |
| K103557 | DIAZYME HS CRP ASSAY KIT / CALIBRATOR SET / CONTROL SET | Diazyme Laboratories | 2011-04-27 | 146 | 0 |
| K061138 | ABX PENTRA 400 : CRP | Horiba Abx | 2006-09-29 | 158 | 0 |
| K060139 | CRP-ADVANCE ASSAY, MODELS 250-20, 250-25 | Diagnostic Chemicals , Ltd. | 2006-04-28 | 99 | 0 |
| K052591 | NANOPIA WIDE RANGE C-REACTIVE PROTEIN (CRP) REAGENT KIT | Clinical Data, Inc. | 2006-02-09 | 141 | 0 |
| K050836 | CRP DIAGNOSTIC ASSAY | Sentinel Ch. Srl | 2005-08-08 | 129 | 0 |
| K041155 | WIDE RANGE C-REACTIVE PROTEIN (WR CRP) ASSAY | Stanbio Laboratory | 2004-10-14 | 164 | 0 |
| K042442 | QUICKREAD SYSTEM: QUICKREAD CRP KIT, MODEL 06085; QUICKREAD | Orion Diagnostica, OY | 2004-09-24 | 15 | 0 |
| K040241 | N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET | Genzyme Corp. | 2004-06-25 | 143 | 0 |
| K040579 | CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) | Cholestech Corp. | 2004-06-18 | 106 | 2 |
| K032663 | QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CR | Instrumentation Laboratory CO | 2003-12-19 | 113 | 0 |
| K031607 | ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL | Orion Diagnostica, Div. Orion Corp. | 2003-10-10 | 141 | 0 |
| K030044 | EXTENDED RANGE HS CRP KIT, CAT NO:9200 | Reference Diagnostics, Inc. | 2003-09-30 | 267 | 0 |
| K024280 | WAKO CRP, CALIBRATOR AND WAKO CRP CALIBRATOR SET | Wako Chemicals USA, Inc. | 2003-06-06 | 165 | 0 |
| K030545 | CRP-LATEX (II)X2 SEIKEN ASSAY KIT | Denka Seiken Co., Ltd. | 2003-06-02 | 102 | 1 |
| K030626 | VITROS CHEMISTRY PRODUCTS CRP SLIDE AND CALIBRATOR KIT 7 | Ortho-Clinical Diagnostics, Inc. | 2003-03-18 | 19 | 3 |
| K023828 | K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR | Kamiya Biomedical Co. | 2003-02-04 | 78 | 1 |
| K023269 | HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSI | Instrumentation Laboratory CO | 2002-12-23 | 83 | 0 |
| K022176 | ORION DIAGNOSTICA ULTRASENSITIVE CRP KIT, MODEL 68025, & ORI | Orion Diagnostica, Div. Orion Corp. | 2002-12-03 | 153 | 0 |
| K022486 | K-ASSAY HS-CRP CONTROLS | Kamiya Biomedical Co. | 2002-08-14 | 16 | 0 |
| K021194 | RAICHEM CRP HIGH SENSITIVITY TEST SYSTEM | Hemagen Diagnostics, Inc. | 2002-07-29 | 105 | 0 |
| K021609 | RDI HS CRP KIT | Reference Diagnostics, Inc. | 2002-06-27 | 42 | 0 |
| K013787 | NYCOCARD CRP | Primus Corp. | 2002-05-14 | 181 | 0 |
| K014084 | NYCOCARD CRP CONTROL | Primus Corp. | 2002-01-07 | 27 | 0 |
| K003851 | BIOCHECK HIGH SENSITIVITY C-REACTIVE PROTEIN ENZYME IMMUNOAS | Biocheck, Inc. | 2001-07-20 | 220 | 0 |
| K010597 | SYNCHRON LX SYSTEMS HIGH SENSITIVITY C-REACTIVE PROTIEN (CRP | Beckman Coulter, Inc. | 2001-05-29 | 90 | 0 |
| K011079 | K-ASSAY HS-CRP CONTROLS | Kamiya Biomedical Co. | 2001-05-16 | 37 | 0 |
| K010236 | IMMAGE IMMUNOCHEMISTRY SYSTEM HIGH SENSITIVITY C-REACTIVE PR | Beckman Coulter, Inc. | 2001-04-05 | 70 | 0 |
| K002558 | K-ASSAY HIGH SENSITIVE CRP(2) FOR THE BECKMAN COULTER IMMAGE | Kamiya Biomedical Co. | 2000-10-25 | 72 | 0 |
| K002651 | C-REACTIVE PROTEIN (HIGH SENSITIVITY) REAGENT SET | Pointe Scientific, Inc., | 2000-10-13 | 49 | 0 |
| K001636 | C-REACTIVE PROTEIN ANTISERUM KIT | The Binding Site, Ltd. | 2000-08-24 | 86 | 0 |
| K001009 | RANDOX C-REACTIVE PROTEIN | Randox Laboratories, Ltd. | 2000-08-04 | 128 | 2 |
| K991385 | DADE BEHRING N HIGH SENSITIVITY CRP ASSAY | Dade Behring, Inc. | 1999-10-25 | 187 | 0 |
| K992311 | K-ASSAY CRP(1), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP | Kamiya Biomedical Co. | 1999-09-13 | 66 | 0 |
| K992312 | K-ASSAY CRP (2), K-ASSAY CRP MULTI-CALIBRATOR A, K-ASSAY CRP | Kamiya Biomedical Co. | 1999-09-13 | 66 | 1 |
| K991224 | K-ASSAY CRP | Kamiya Biomedical Co. | 1999-05-14 | 32 | 0 |
| K991210 | K-ASSAY CRP CALIBRATOR SET | Kamiya Biomedical Co. | 1999-05-11 | 32 | 0 |
| K990704 | ARRAY 360 SYSTEM C-REACTIVE PROTEIN (CRP MPE) REAGENT | Beckman Coulter, Inc. | 1999-05-03 | 60 | 0 |
| K990886 | IMMULITE C-REACTIVE PROTEIN, MODEL LKCR1, LKCR5 | Diagnostic Products Corp. | 1999-04-06 | 20 | 0 |
| K984132 | IMMULITE C-REACTIVE PROTEIN, MODELS LKC1, LKC5 | Diagnostic Products Corp. | 1999-01-28 | 71 | 0 |
| K981871 | C-REACTIVE PROTEIN ELISA, MODEL NUMBER DSL-10-42100 | Diagnostic Systems Laboratories, Inc. | 1998-11-09 | 165 | 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