C-Reactive Protein Kit for use on SPAPLUS
FDA 510(k) K161982 · The Binding Site Group
510(k) numberK161982
Submission
- Device name
- C-Reactive Protein Kit for use on SPAPLUS
- Applicant
- The Binding Site Group
Birmingham, GB - Received
- July 19, 2016
- Decision date
- April 5, 2017
- 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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| K180099 | Optilite High Sensitivity C-Reactive Protein KitDCN · Traditional | 10/12/2018SE |
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Questions and answers
When was C-Reactive Protein Kit for use on SPAPLUS cleared by the FDA?
C-Reactive Protein Kit for use on SPAPLUS (K161982) received a 510(k) decision of Substantially Equivalent on April 5, 2017, 260 days after the submission was received.
What is the product code of K161982?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.