Cleared Traditional

Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator

K150412 · The Binding Site Group , Ltd. · Immunology
Aug 2015
Decision
191d
Days
Class 2
Risk

About This 510(k) Submission

K150412 is an FDA 510(k) clearance for the Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator, a Complement C9, Antigen, Antiserum, Control (Class II — Special Controls, product code DAE), submitted by The Binding Site Group , Ltd. (Birmingham, GB). The FDA issued a Cleared decision on August 28, 2015, 191 days after receiving the submission on February 18, 2015. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K150412 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 2015
Decision Date August 28, 2015
Days to Decision 191 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DAE — Complement C9, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

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