Cleared Traditional

CMV EARLY ANTIGEN TEST

K942171 · Neogenex · Microbiology
Jun 1994
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K942171 is an FDA 510(k) clearance for the CMV EARLY ANTIGEN TEST, a Antiserum, Cf, Cytomegalovirus (Class II — Special Controls, product code GQI), submitted by Neogenex (Everett, US). The FDA issued a Cleared decision on June 30, 1994, 56 days after receiving the submission on May 5, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3175.

Submission Details

510(k) Number K942171 FDA.gov
FDA Decision Cleared SESE
Date Received May 05, 1994
Decision Date June 30, 1994
Days to Decision 56 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code GQI — Antiserum, Cf, Cytomegalovirus
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3175

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