Cleared Traditional

Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls

K172868 · The Binding Site Group , Ltd. · Immunology
Feb 2018
Decision
161d
Days
Class 2
Risk

About This 510(k) Submission

K172868 is an FDA 510(k) clearance for the Optilite C-Reactive Protein Reagent,Optilite C-Reactive Protein Calibrator,Optilite C-Reactive Protein Controls, a System, Test, C-reactive Protein (Class II — Special Controls, product code DCN), submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on February 28, 2018, 161 days after receiving the submission on September 20, 2017. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K172868 FDA.gov
FDA Decision Cleared SESE
Date Received September 20, 2017
Decision Date February 28, 2018
Days to Decision 161 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DCN — System, Test, C-reactive Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5270

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