Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRP
FDA 510(k) K063057 · Diagnostic Products Corporation
510(k) numberK063057
Submission
- Device name
- Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRP
- Applicant
- Diagnostic Products Corporation
Los Angeles, CA, US - Received
- October 5, 2006
- Decision date
- December 22, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQD – Cardiac C-Reactive Protein, Antigen, Antiserum, And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
In vitro diagnostic test to measure C-reactive protein for the purpose of making cardiac risk assessments.
Other 510(k)s with product code NQD
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|---|---|---|---|
| K260026 | Tina-quant Cardiac high sensitivity CRP IIINQD · Traditional | Roche Diagnostics | 04/02/2026SE |
| K233242 | Atellica® CH High Sensitivity C-Reactive Protein 2 (hCRP2)NQD · Traditional | Siemens Healthcare Diagnostics, Inc. | 01/18/2024SE |
| K212559 | CardioPhase® hsCRPNQD · Special | Siemens Healthcare Diagnostics Products GmbH | 12/16/2022SE |
| K173833 | CRP VarioNQD · Traditional | SENTINEL CH. SpA | 09/27/2018SE |
| K081294 | Advia Chemistry Cardiophase High Sensitivity C-Reactive Protein (Hscrp), CalibratorsNQD · Traditional | Siemens Healthcare Diagnostics, Inc. | 07/29/2008SE |
| K071002 | Immage Immunochemistry Systems High Sensitivity Cardiac C-Reactive Protein (CCRP) ReagentNQD · Traditional | Beckman Coulter, Inc. | 06/21/2007SE |
| K070626 | Synchron Systems High Sensitivity Cardiac C-Reactive Protein (CRPH) ReagentNQD · Traditional | Beckman Coulter, Inc. | 05/04/2007SE |
| K071017 | Immulite 2500 High Sensitivity C-Reactive Protein, Models L5KCRP (200 Tests), L5KCRP…NQD · Special | Siemens Medical Solutions Diagnostics | 05/02/2007SE |
| K062924 | Stratus CS Acute Care Cardiophase Hscrp TestpakNQD · Traditional | Dade Behring, Inc. | 12/26/2006SE |
| K061802 | Dimension Vista Cardiophase Hscrp Flex Reagent Cartridge, Protein 2 Calibrator, Hscrp…NQD · Traditional | Dade Behring, Inc. | 09/11/2006SE |
More from Dade Behring, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K063045 | Immulite 2000, Immulite 2500 VancomycinLEH · Traditional | 12/05/2006SE |
| K060929 | Immulite 2500 Vitamin B12 Model L5KVB2-200 TEST,L5KVB6-600 Test, Immulite 2500 Folic…CDD · Special | 04/28/2006SE |
| 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 |
| K022118 | Immulite Turbo Ck-Mb, Models LSKCP1 (100 Tests), LSKCP5 (500 Tests)JHX · Special | 07/22/2002SE |
Questions and answers
When was Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRP cleared by the FDA?
Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRP (K063057) received a 510(k) decision of Substantially Equivalent on December 22, 2006, 78 days after the submission was received.
What is the product code of K063057?
The FDA product code is NQD – Cardiac C-Reactive Protein, Antigen, Antiserum, And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5270.