Cleared Traditional

Rheumatoid Factor (RF) Kit for use on SPAPLUS

K160070 · The Binding Site Group , Ltd. · Immunology
Dec 2016
Decision
329d
Days
Class 2
Risk

About This 510(k) Submission

K160070 is an FDA 510(k) clearance for the Rheumatoid Factor (RF) Kit for use on SPAPLUS, a System, Test, Rheumatoid Factor (Class II — Special Controls, product code DHR), submitted by The Binding Site Group , Ltd. (Edgbaston, GB). The FDA issued a Cleared decision on December 7, 2016, 329 days after receiving the submission on January 13, 2016. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5775.

Submission Details

510(k) Number K160070 FDA.gov
FDA Decision Cleared SESE
Date Received January 13, 2016
Decision Date December 07, 2016
Days to Decision 329 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DHR — System, Test, Rheumatoid Factor
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5775

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