Cleared Traditional

Optilite Low Level Albumin Kit

K153560 · The Binding Site Group , Ltd. · Immunology
Aug 2016
Decision
255d
Days
Class 2
Risk

About This 510(k) Submission

K153560 is an FDA 510(k) clearance for the Optilite Low Level Albumin 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 August 25, 2016, 255 days after receiving the submission on December 14, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5040.

Submission Details

510(k) Number K153560 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2015
Decision Date August 25, 2016
Days to Decision 255 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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