Cleared Special

Optilite IgM Kit

K191635 · The Binding Site Group , Ltd. · Immunology
Jul 2019
Decision
26d
Days
Class 2
Risk

About This 510(k) Submission

K191635 is an FDA 510(k) clearance for the Optilite IgM Kit, 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 July 15, 2019, 26 days after receiving the submission on June 19, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K191635 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2019
Decision Date July 15, 2019
Days to Decision 26 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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