HUMAN CAERULOPLASMIN KIT— 510(k) K122965

Name: FDA 510(k) clearance K122965
Creator: U.S. Food and Drug Administration
Published: 2013-06-03

Substantially Equivalent

The Binding Site Group , Ltd.

FDA 510(k) clearance K122965 for HUMAN CAERULOPLASMIN KIT, Substantially Equivalent on 2013-06-03. Applicant: The Binding Site Group , Ltd.. Device class: 2.

Clearance details

Applicant: The Binding Site Group , Ltd.
Product code: Code DDB
Device class: Class 2
Regulation: 21 CFR 866.5210
Advisory panel: Immunology
Date received: 2012-09-24
Decision date: 2013-06-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Birmingham, GB

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.