Optilite High Sensitivity C-Reactive Protein Kit
FDA 510(k) K180099 · The Binding Site Group , Ltd.
510(k) numberK180099
Submission
- Device name
- Optilite High Sensitivity C-Reactive Protein Kit
- Applicant
- The Binding Site Group , Ltd.
Birmingham, GB - Received
- January 16, 2018
- Decision date
- October 12, 2018
- 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 Optilite High Sensitivity C-Reactive Protein Kit cleared by the FDA?
Optilite High Sensitivity C-Reactive Protein Kit (K180099) received a 510(k) decision of Substantially Equivalent on October 12, 2018, 269 days after the submission was received.
What is the product code of K180099?
The FDA product code is DCN – System, Test, C-Reactive Protein, a Class II (moderate risk) device regulated under 21 CFR 866.5270.