Cleared Traditional

Optilite High Sensitivity C-Reactive Protein Kit

K180099 · The Binding Site Group , Ltd. · Chemistry
Oct 2018
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K180099 is an FDA 510(k) clearance for the Optilite High Sensitivity C-Reactive Protein Kit, 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 October 12, 2018, 269 days after receiving the submission on January 16, 2018. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5270.

Submission Details

510(k) Number K180099 FDA.gov
FDA Decision Cleared SESE
Date Received January 16, 2018
Decision Date October 12, 2018
Days to Decision 269 days
Submission Type Traditional
Review Panel Chemistry (CH)
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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