Cleared Traditional

The Optilite IgG3 kit

K142735 · The Binding Site Group , Ltd. · Immunology
Dec 2014
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K142735 is an FDA 510(k) clearance for the The Optilite IgG3 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 December 21, 2014, 89 days after receiving the submission on September 23, 2014. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K142735 FDA.gov
FDA Decision Cleared SESE
Date Received September 23, 2014
Decision Date December 21, 2014
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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