Optilite High Sensitivity C-Reactive Protein Kit— 510(k) K180099

Name: FDA 510(k) clearance K180099
Creator: U.S. Food and Drug Administration
Published: 2018-10-12

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K180099 for Optilite High Sensitivity C-Reactive Protein Kit, Substantially Equivalent on 2018-10-12. Applicant: The Binding Site Group , Ltd.. Device class: 2.

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code DCN
Device class: Class 2
Regulation: 21 CFR 866.5270
Advisory panel: Immunology
Date received: 2018-01-16
Decision date: 2018-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, GB

Download summary PDF View on FDA.gov ↗

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