Cleared Traditional

Optilite IgG4 Kit

K150526 · The Binding Site Group , Ltd. · Immunology
May 2015
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K150526 is an FDA 510(k) clearance for the Optilite IgG4 Kit, 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 May 30, 2015, 89 days after receiving the submission on March 2, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K150526 FDA.gov
FDA Decision Cleared SESE
Date Received March 02, 2015
Decision Date May 30, 2015
Days to Decision 89 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

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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