Devices descending from K991385
32 later devices reach Dade Behring N High Sensitivity CRP Assay through their predicates, nearest generation first.
| Generation | Number | Device | Applicant | Decided | Own descendants | Recalls |
|---|---|---|---|---|---|---|
| +1 | K063057 | Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRP | Diagnostic Products Corporation | 2006 | 1 | — |
| +1 | K033908 | N High Sensitivity CRP | Dade Behring, Inc. | 2004 | 23 | — |
| +1 | K032663 | Quantex CRP High Sensitivity Standard Multipoint, Quantex CRP High Sensitivity Controls… | Instrumentation Laboratory CO | 2003 | 0 | — |
| +1 | K030899 | C-Reactive Protein (CRP) | Abbott Laboratories | 2003 | 0 | — |
| +1 | K030545 | CRP-Latex (II)X2 Seiken Assay Kit | Denka Seiken Co., Ltd. | 2003 | 2 | 1 |
| +1 | K023269 | Hemosil C-Reactive Protein - High Sensitivity and High Sensitivity Controls | Instrumentation Laboratory CO | 2002 | 0 | — |
| +1 | K011855 | Wampole HS-CRP Elisa | Carter-Wallace, Inc. | 2002 | 0 | — |
| +1 | K012337 | Bayer Advia Ims System; C-Reactive Protein System | Bayer Corp. | 2001 | 0 | — |
| +2 | K212559 | CardioPhase® hsCRP | Siemens Healthcare Diagnostics Products GmbH | 2022 | 1 | — |
| +2 | K081294 | Advia Chemistry Cardiophase High Sensitivity C-Reactive Protein (Hscrp), Calibrators | Siemens Healthcare Diagnostics, Inc. | 2008 | 0 | 2 |
| +2 | K071002 | Immage Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein (CCRP) Reagent | Beckman Coulter, Inc. | 2007 | 0 | — |
| +2 | K070626 | Synchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) Reagent | Beckman Coulter, Inc. | 2007 | 1 | — |
| +2 | K071017 | Immulite 2500 High Sensitivity C-Reactive Protein, Models L5KCRP (200 Tests), L5KCRP… | Siemens Medical Solutions Diagnostics | 2007 | 0 | — |
| +2 | K061802 | Dimension Vista Cardiophase Hscrp Flex Reagent Cartridge, Protein 2 Calibrator, Hscrp… | Dade Behring, Inc. | 2006 | 0 | — |
| +2 | K061825 | Dimension Vista CRP Flex Reagent Cartridge, Protein 2 Calibrator, Control Low and… | Dade Behring, Inc. | 2006 | 0 | — |
| +2 | K060369 | Stratus CS Acute Care Cardiophase Hscrp Test Pak, Calpak, Dilpak | Dade Behring, Inc. | 2006 | 1 | 1 |
| +2 | K053603 | C-Reactive Protein (Latex) High Sensitive Test System for Cobas Integra Instruments | Roche Diagnostics Corp. | 2006 | 2 | — |
| +2 | K050836 | CRP Diagnostic Assay | Sentinel Ch. Srl | 2005 | 1 | — |
| +2 | K042485 | Tina-Quant CRP (Latex) HS Test System (C-Reactive Protein (Latex) High Sensitive) | Roche Diagnostics Corp. | 2004 | 7 | 1 |
| +2 | K041799 | Vitros Chemistry Products Hscrp Reagent, Vitros Chemistry Products Calibrator Kit 17… | Ortho-Clinical Diagnostics, Inc. | 2004 | 2 | 3 |
| +3 | K260026 | Tina-quant Cardiac high sensitivity CRP III | Roche Diagnostics | 2026 | 0 | — |
| +3 | K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2) | Siemens Healthcare Diagnostics, Inc. | 2024 | 0 | — |
| +3 | K192118 | CRP Vario | SENTINEL CH. SpA | 2019 | 0 | — |
| +3 | K180099 | Optilite High Sensitivity C-Reactive Protein Kit | The Binding Site Group, Ltd. | 2018 | 0 | — |
| +3 | K141689 | FastPack High Sensitivity C-Reactive Protein Immunoassay, High Sensitivity C-Reactive… | Qualigen, Inc. | 2015 | 0 | — |
| +3 | K103557 | Diazyme HS CRP Assay Kit / Calibrator Set / Control Set | Diazyme Laboratories | 2011 | 3 | — |
| +3 | K091052 | Piccolo C-Reactive Protein (CRP) Test System | Abaxis, Inc. | 2010 | 0 | — |
| +3 | K062924 | Stratus CS Acute Care Cardiophase Hscrp Testpak | Dade Behring, Inc. | 2006 | 0 | 1 |
| +3 | K042838 | Vitros Chemistry Products Calibrator Kit 23; Vitros Chemistry Products Palb Performance… | Ortho-Clinical Diagnostics, Inc. | 2004 | 0 | — |
| +4 | K160712 | VITROS Chemistry Products hsCRP Reagent | Ortho Clinical Diagnostics | 2017 | 1 | — |
| +4 | K121558 | Diazyme Hscrp Poc Test Kit | Diazyme Laboratories | 2012 | 0 | — |
| +5 | K191993 | Yumizen C1200 CRP | Horiba Abx Sas | 2019 | 0 | — |