Dimension Vista CRP Flex Reagent Cartridge, Protein 2 Calibrator, Control Low and Control High
FDA 510(k) K061825 · Dade Behring, Inc.
510(k) numberK061825
Submission
- Device name
- Dimension Vista CRP Flex Reagent Cartridge, Protein 2 Calibrator, Control Low and Control High
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- June 28, 2006
- Decision date
- September 6, 2006
- 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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Questions and answers
When was Dimension Vista CRP Flex Reagent Cartridge, Protein 2 Calibrator, Control Low and Control High cleared by the FDA?
Dimension Vista CRP Flex Reagent Cartridge, Protein 2 Calibrator, Control Low and Control High (K061825) received a 510(k) decision of Substantially Equivalent on September 6, 2006, 70 days after the submission was received.
What is the product code of K061825?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.