Cleared Traditional

C-Reactive Protein Kit for use on SPAPLUS

K161982 · The Binding Site Group · Immunology

Apr 2017

Decision

260d

Days

Class 2

Risk

About This 510(k) Submission

K161982 is an FDA 510(k) clearance for the C-Reactive Protein Kit for use on SPAPLUS, a System, Test, C-reactive Protein (Class II — Special Controls, product code DCN), submitted by The Binding Site Group (Birmingham, GB). The FDA issued a Cleared decision on April 5, 2017, 260 days after receiving the submission on July 19, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number	K161982 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 19, 2016
Decision Date	April 05, 2017
Days to Decision	260 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF