Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

NQD — Predicate Candidate Screening

19 FDA 510(k) clearances under this product code; the 50 most recent screened below.

73 daysmedian FDA review time
283 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K260026Tina-quant Cardiac high sensitivity CRP IIIRoche Diagnostics2026-04-02870
K233242Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)Siemens Healthcare Diagnostics, Inc.2024-01-181120
K212559CardioPhase® hsCRPSiemens Healthcare Diagnostics Products GmbH2022-12-164900
K173833CRP VarioSENTINEL CH. SpA2018-09-272830
K081294ADVIA CHEMISTRY CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTSiemens Healthcare Diagnostics, Inc.2008-07-29830
K071002IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REBeckman Coulter, Inc.2007-06-21730
K070626SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEINBeckman Coulter, Inc.2007-05-04590
K071017IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5Siemens Medical Solutions Diagnostics2007-05-02220
K062924STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAKDade Behring, Inc.2006-12-26891
K063057IMMULITE/IMMULITE 1000, IMMULITE 2000 HIGH SENSITIVITY CRPDiagnostic Products Corporation2006-12-22780
K061802DIMENSION VISTA CARDIOPHASE HSCRP FLEX REAGENT CARTRIDGE, PRDade Behring, Inc.2006-09-11760
K060369STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TEST PAK, CALPAK, DIDade Behring, Inc.2006-05-04801
K053603C-REACTIVE PROTEIN (LATEX) HIGH SENSITIVE TEST SYSTEM FOR CORoche Diagnostics Corp.2006-02-09480
K053109DIMENSION CARDIOPHASE HIGH SENSITIVITY CRP FLEX REAGENT CARTDade Behring, Inc.2005-12-23490
K051564OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBROlympus America, Inc.2005-08-22690
K042485TINA-QUANT CRP (LATEX) HS TEST SYSTEM (C-REACTIVE PROTEIN (LRoche Diagnostics Corp.2004-10-29461
K041799VITROS CHEMISTRY PRODUCTS HSCRP REAGENT, VITROS CHEMISTRY PROrtho-Clinical Diagnostics, Inc.2004-08-25542
K041668OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENTOlympus America, Inc.2004-08-19620
K033908N HIGH SENSITIVITY CRPDade Behring, Inc.2004-01-22360

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