C-Reactive Protein (Latex)
FDA 510(k) K083444 · Roche Diagnostics Corp.
510(k) numberK083444
Submission
- Device name
- C-Reactive Protein (Latex)
- Applicant
- Roche Diagnostics Corp.
Indianapolis, IN, US - Received
- November 21, 2008
- Decision date
- March 18, 2009
- 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 C-Reactive Protein (Latex) cleared by the FDA?
C-Reactive Protein (Latex) (K083444) received a 510(k) decision of Substantially Equivalent on March 18, 2009, 117 days after the submission was received.
What is the product code of K083444?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.