Hemosil C-Reactive Protein - High Sensitivity and High Sensitivity Controls
FDA 510(k) K023269 · Instrumentation Laboratory CO
510(k) numberK023269
Submission
- Device name
- Hemosil C-Reactive Protein - High Sensitivity and High Sensitivity Controls
- Applicant
- Instrumentation Laboratory CO
Bedford, MA, US - Received
- October 1, 2002
- Decision date
- December 23, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DCK – C-Reactive Protein, Antigen, Antiserum, And Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5270
- Specialty
- Immunology
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Questions and answers
When was Hemosil C-Reactive Protein - High Sensitivity and High Sensitivity Controls cleared by the FDA?
Hemosil C-Reactive Protein - High Sensitivity and High Sensitivity Controls (K023269) received a 510(k) decision of Substantially Equivalent on December 23, 2002, 83 days after the submission was received.
What is the product code of K023269?
The FDA product code is DCK – C-Reactive Protein, Antigen, Antiserum, And Control, a Class II (moderate risk) device regulated under 21 CFR 866.5270.