C-Reactive Protein Immunoturbidimetric Kit & CRP Calibrator
FDA 510(k) K953212 · Randox Laboratories, Ltd.
510(k) numberK953212
Submission
- Device name
- C-Reactive Protein Immunoturbidimetric Kit & CRP Calibrator
- Applicant
- Randox Laboratories, Ltd.
Crumlin, IE - Received
- July 10, 1995
- Decision date
- July 31, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 C-Reactive Protein Immunoturbidimetric Kit & CRP Calibrator cleared by the FDA?
C-Reactive Protein Immunoturbidimetric Kit & CRP Calibrator (K953212) received a 510(k) decision of Substantially Equivalent on July 31, 1995, 21 days after the submission was received.
What is the product code of K953212?
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.