Stratus CS Acute Care Cardiophase Hscrp Testpak
FDA 510(k) K062924 · Dade Behring, Inc.
510(k) numberK062924
Submission
- Device name
- Stratus CS Acute Care Cardiophase Hscrp Testpak
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- September 28, 2006
- Decision date
- December 26, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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.
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| K071017 | Immulite 2500 High Sensitivity C-Reactive Protein, Models L5KCRP (200 Tests), L5KCRP…NQD · Special | Siemens Medical Solutions Diagnostics | 05/02/2007SE |
| K063057 | Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPNQD · Abbreviated | Diagnostic Products Corporation | 12/22/2006SE |
| K061802 | Dimension Vista Cardiophase Hscrp Flex Reagent Cartridge, Protein 2 Calibrator, Hscrp…NQD · Traditional | Dade Behring, Inc. | 09/11/2006SE |
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Questions and answers
When was Stratus CS Acute Care Cardiophase Hscrp Testpak cleared by the FDA?
Stratus CS Acute Care Cardiophase Hscrp Testpak (K062924) received a 510(k) decision of Substantially Equivalent on December 26, 2006, 89 days after the submission was received.
What is the product code of K062924?
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.