C-Reactive Protein Antiserum Kit
FDA 510(k) K001636 · The Binding Site, Ltd.
510(k) numberK001636
Submission
- Device name
- C-Reactive Protein Antiserum Kit
- Applicant
- The Binding Site, Ltd.
Santa Monica, CA, US - Received
- May 30, 2000
- Decision date
- August 24, 2000
- 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 Antiserum Kit cleared by the FDA?
C-Reactive Protein Antiserum Kit (K001636) received a 510(k) decision of Substantially Equivalent on August 24, 2000, 86 days after the submission was received.
What is the product code of K001636?
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.