Immulite High Sensitivity CRP, Immulite 2000 High Sensitivity CRP
FDA 510(k) K003372 · Diagnostic Products Corp.
510(k) numberK003372
Submission
- Device name
- Immulite High Sensitivity CRP, Immulite 2000 High Sensitivity CRP
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- October 30, 2000
- Decision date
- December 26, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DCN – System, Test, C-Reactive Protein
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
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| K221119 | RCRP Flex reagent cartridgeDCN · Special | Siemens Healthcare Diagnostics, Inc. | 03/17/2023SE |
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| K180099 | Optilite High Sensitivity C-Reactive Protein KitDCN · Traditional | The Binding Site Group , Ltd. | 10/12/2018SE |
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| K171498 | MSD CRP Assay Kit and MESO SECTOR S 700 InstrumentDCN · Traditional | Meso Scale Diagnostics, LLC | 01/12/2018SE |
| K161982 | C-Reactive Protein Kit for use on SPAPLUSDCN · Traditional | The Binding Site Group | 04/05/2017SE |
| K113809 | Hitachi Clinical Analyzer S Test Regent Cartridge C-Reactive Protein (CRP)DCN · Traditional | Hitachi Chemical Diagnostics, Inc. | 08/17/2012SE |
| K091052 | Piccolo C-Reactive Protein (CRP) Test SystemDCN · Traditional | Abaxis, Inc. | 01/15/2010SE |
| K083444 | C-Reactive Protein (Latex)DCN · Traditional | Roche Diagnostics Corp. | 03/18/2009SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K063057 | Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPNQD · Abbreviated | 12/22/2006SE |
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| K053533 | Immulite/Immulite 1000 Turbo Intact PTHCEW · Traditional | 02/03/2006SE |
| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | 01/21/2004SE |
| K033234 | Immulite 2500 Automated Immunoassay AnalyzerDHA · Traditional | 12/12/2003SE |
| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special | 10/10/2003SE |
| K023152 | Immulite 2000 Allergen-Specific IgeDHB · Abbreviated | 12/17/2002SE |
| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | 12/09/2002SE |
| K022603 | Immulite 1000 Automated Immunoassay AnalyzerCEW · Special | 08/21/2002SE |
Questions and answers
When was Immulite High Sensitivity CRP, Immulite 2000 High Sensitivity CRP cleared by the FDA?
Immulite High Sensitivity CRP, Immulite 2000 High Sensitivity CRP (K003372) received a 510(k) decision of Substantially Equivalent on December 26, 2000, 57 days after the submission was received.
What is the product code of K003372?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.