Cleared Traditional

HUMAN ALBUMIN CSF KIT

K121045 · The Binding Site Group , Ltd. · Immunology
Jun 2013
Decision
439d
Days
Class 2
Risk

About This 510(k) Submission

K121045 is an FDA 510(k) clearance for the HUMAN ALBUMIN CSF KIT, a Albumin, Antigen, Antiserum, Control (Class II — Special Controls, product code DCF), submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on June 19, 2013, 439 days after receiving the submission on April 6, 2012. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5040.

Submission Details

510(k) Number K121045 FDA.gov
FDA Decision Cleared SESE
Date Received April 06, 2012
Decision Date June 19, 2013
Days to Decision 439 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DCF — Albumin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5040

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