Cleared Special

Human IgA liquid reagent kit for Use on SPAPlus

K192116 · The Binding Site Group , Ltd. · Immunology
Sep 2019
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K192116 is an FDA 510(k) clearance for the Human IgA liquid reagent kit for Use on SPAPlus, a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFN), submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on September 4, 2019, 29 days after receiving the submission on August 6, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K192116 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 2019
Decision Date September 04, 2019
Days to Decision 29 days
Submission Type Special
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code CFN — Method, Nephelometric, Immunoglobulins (g, A, M)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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