Cleared Special

Optilite IgA Kit

K191985 · The Binding Site Group , Ltd. · Immunology
Aug 2019
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K191985 is an FDA 510(k) clearance for the Optilite IgA 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 August 19, 2019, 25 days after receiving the submission on July 25, 2019. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K191985 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 2019
Decision Date August 19, 2019
Days to Decision 25 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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