Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DCN — Predicate Candidate Screening
70 FDA 510(k) clearances under this product code; the 50 most recent screened below.
70 daysmedian FDA review time
234 days90th percentile
70clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232624 | CardioPhase® hsCRP | Siemens Healthcare Diagnostic Products GmbH | 2023-11-27 | 90 | 0 |
| K221119 | RCRP Flex reagent cartridge | Siemens Healthcare Diagnostics, Inc. | 2023-03-17 | 333 | 1 |
| K192072 | Tina-quant C-Reactive Protein IV | Roche Diagnostics Operations (Rdo) | 2020-02-21 | 203 | 0 |
| K180099 | Optilite High Sensitivity C-Reactive Protein Kit | The Binding Site Group , Ltd. | 2018-10-12 | 269 | 0 |
| K172868 | Optilite C-Reactive Protein Reagent,Optilite C-Reactive Prot | The Binding Site Group , Ltd. | 2018-02-28 | 161 | 1 |
| K171498 | MSD CRP Assay Kit and MESO SECTOR S 700 Instrument | Meso Scale Diagnostics, LLC | 2018-01-12 | 234 | 0 |
| K161982 | C-Reactive Protein Kit for use on SPAPLUS | The Binding Site Group | 2017-04-05 | 260 | 1 |
| K113809 | HITACHI CLINICAL ANALYZER S TEST REGENT CARTRIDGE C-REACTIVE | Hitachi Chemical Diagnostics, Inc. | 2012-08-17 | 238 | 0 |
| K091052 | PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM | Abaxis, Inc. | 2010-01-15 | 277 | 0 |
| K083444 | C-REACTIVE PROTEIN (LATEX) | Roche Diagnostics Corp. | 2009-03-18 | 117 | 0 |
| K083412 | PATHFAST HSCRP | Mitsubishi Kagaku Iatron | 2009-03-09 | 111 | 0 |
| K083040 | S-TEST C-REACTIVE PROTEIN (CRP) | Alfa Wassermann Diagnostic Technologies, Inc. | 2009-01-30 | 108 | 0 |
| K072658 | ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATOR | Siemens Medical Solutions Diagnostics | 2008-04-01 | 194 | 0 |
| K073277 | ROCHE-CREACTIVE PROTEIN (LATEX) | Roche Diagnostics Corp. | 2008-03-06 | 106 | 0 |
| K062981 | I-CHROMA CRP TEST | Boditech Diagnostics, Inc. | 2007-07-13 | 287 | 0 |
| K061825 | DIMENSION VISTA CRP FLEX REAGENT CARTRIDGE, PROTEIN 2 CALIBR | Dade Behring, Inc. | 2006-09-06 | 70 | 0 |
| K050713 | DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CAL | Good Biotech Corp. | 2005-06-06 | 80 | 0 |
| K040030 | BIOCHECK CARDIAC-1 CRP RAPID TEST, MODEL BC-804114 | Biocheck, Inc. | 2004-06-16 | 161 | 0 |
| K032336 | TINA-QUANT CRP (LATEX) | Roche Diagnostics Corp. | 2003-08-05 | 7 | 0 |
| K030899 | C-REACTIVE PROTEIN (CRP) | Abbott Laboratories | 2003-07-02 | 100 | 0 |
| K022690 | PAROS CRP | Horiba, Ltd. | 2002-12-23 | 132 | 0 |
| K021757 | CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRAT | Good Biotech Corp. | 2002-07-29 | 61 | 0 |
| K021572 | SYNCHRON SYSTEMS C-REACTIVE PROTEIN (C-RP) REAGENT; SYNCHRON | Beckman Coulter, Inc. | 2002-07-19 | 66 | 0 |
| K021882 | CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 | Good Biotech Corp. | 2002-07-11 | 34 | 0 |
| K020603 | CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 | Good Biotech Corp. | 2002-06-13 | 108 | 0 |
| K011855 | WAMPOLE HS-CRP ELISA | Carter-Wallace, Inc. | 2002-01-08 | 209 | 0 |
| K012337 | BAYER ADVIA IMS SYSTEM; C-REACTIVE PROTEIN SYSTEM | Bayer Corp. | 2001-12-06 | 135 | 0 |
| K011958 | CRP-LATEX (II) SEIKEN HIGH SENSITIVITY ASSAY KIT | Denka Seiken'S | 2001-12-04 | 165 | 0 |
| K003400 | CRP HS TEST SYSTEM | Roche Diagnostics Corp. | 2001-05-10 | 190 | 0 |
| K003419 | RCRP FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 2001-02-14 | 104 | 1 |
| K003342 | WAKO CRP-UL, CRP-UL CALIBRATOR SET | Wako Chemicals USA, Inc. | 2001-01-22 | 89 | 0 |
| K003372 | IMMULITE HIGH SENSITIVITY CRP, IMMULITE 2000 HIGH SENSITIVIT | Diagnostic Products Corp. | 2000-12-26 | 57 | 0 |
| K002918 | OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 2000-10-25 | 36 | 0 |
| K991372 | CRP | Abbott Laboratories | 1999-06-01 | 42 | 0 |
| K990825 | REVISED C-REACTIVE PROTEIN (RCRP) FLEX REAGENT CARTRIDGE | Dade Behring, Inc. | 1999-04-16 | 35 | 0 |
| K974429 | RAPET CRP | Stanbio Laboratory | 1998-02-18 | 86 | 0 |
| K954537 | OLYMPUS C-REACTIVE PROTEIN IMMUNOTURBIDIMETRIC REAGENT | Olympus America, Inc. | 1996-02-14 | 138 | 0 |
| K955042 | CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEM | Shared Systems, Inc. | 1995-12-13 | 40 | 0 |
| K935075 | SPQ CRP CONTROL LEVEL II | Incstar Corp. | 1994-01-11 | 78 | 0 |
| K932180 | EYE SPOT CRP TEST | J.S. Medical Assoc. | 1993-08-23 | 110 | 0 |
| K910535 | SYNCHRON C-REACTIVE PROTEIN REAGENT | Beckman Instruments, Inc. | 1991-04-12 | 63 | 0 |
| K910686 | RHEUMAJET CRP | Biokit USA, Inc. | 1991-03-19 | 28 | 0 |
| K904497 | CROMATEST RHEUMATOID DIAGNOSTIC/CRP LATEX TEST | Biotrax, Inc. | 1990-11-01 | 30 | 0 |
| K903853 | RAPITEX (R) CRP NEW | Behring Diagnostics, Inc. | 1990-08-30 | 9 | 0 |
| K902593 | RAICHEM(TM) SPIA(TM) CRP REAGENT | Reagents Applications, Inc. | 1990-06-28 | 16 | 0 |
| K896272 | QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL | Biokit USA, Inc. | 1989-11-08 | 9 | 0 |
| K892231 | V-TREND TARGET CRP TEST | Texas Immunology, Inc. | 1989-04-21 | 17 | 0 |
| K885001 | QM300 PCR ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1988-12-20 | 19 | 0 |
| K883515 | DU PONT DIMENSION C-REACTIVE PROTEIN METHOD | E.I. Dupont DE Nemours & Co., Inc. | 1988-09-22 | 36 | 0 |
| K882374 | WAKO(TM) CRP | Wako Chemicals USA, Inc. | 1988-07-08 | 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