Cleared Traditional

Human Microalbumin kit for use on SPAPLUS

K143118 · The Binding Site Group , Ltd. · Chemistry
May 2015
Decision
208d
Days
Class 2
Risk

About This 510(k) Submission

K143118 is an FDA 510(k) clearance for the Human Microalbumin kit for use on SPAPLUS, 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 May 26, 2015, 208 days after receiving the submission on October 30, 2014. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5040.

Submission Details

510(k) Number K143118 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 2014
Decision Date May 26, 2015
Days to Decision 208 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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