Cleared Special

Human IgM Kit for use on SPAPlus

K191465 · The Binding Site Group , Ltd. · Immunology
Jun 2019
Decision
24d
Days
Class 2
Risk

About This 510(k) Submission

K191465 is an FDA 510(k) clearance for the Human IgM 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. (Edgbaston, GB). The FDA issued a Cleared decision on June 27, 2019, 24 days after receiving the submission on June 3, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K191465 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2019
Decision Date June 27, 2019
Days to Decision 24 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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