Cleared Traditional

K122965 - HUMAN CAERULOPLASMIN KIT
(FDA 510(k) Clearance)

K122965 · The Binding Site Group , Ltd. · Immunology

Jun 2013

Decision

252d

Days

Class 2

Risk

K122965 is an FDA 510(k) clearance for the HUMAN CAERULOPLASMIN KIT. This device is classified as a Ceruloplasmin, Antigen, Antiserum, Control (Class II — Special Controls, product code DDB).

Submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on June 3, 2013, 252 days after receiving the submission on September 24, 2012.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.5210.

Submission Details

510(k) Number	K122965 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 24, 2012
Decision Date	June 03, 2013
Days to Decision	252 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Statement