Cleared Traditional

Optilite IgM CSF Kit

K190686 · The Binding Site Group , Ltd. · Immunology
May 2019
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K190686 is an FDA 510(k) clearance for the Optilite IgM CSF 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 May 28, 2019, 71 days after receiving the submission on March 18, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K190686 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2019
Decision Date May 28, 2019
Days to Decision 71 days
Submission Type Traditional
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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