Cleared Traditional

OLYMPUS IGA REAGENT

K073489 · Olympus America, Inc. · Immunology
Feb 2008
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K073489 is an FDA 510(k) clearance for the OLYMPUS IGA REAGENT, a Method, Nephelometric, Immunoglobulins (g, A, M) (Class II — Special Controls, product code CFN), submitted by Olympus America, Inc. (Co. Clare, IE). The FDA issued a Cleared decision on February 11, 2008, 61 days after receiving the submission on December 12, 2007. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K073489 FDA.gov
FDA Decision Cleared SESE
Date Received December 12, 2007
Decision Date February 11, 2008
Days to Decision 61 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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