Cleared Traditional

EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY

K946353 · Mrl Diagnostics · Microbiology
Jul 1995
Decision
203d
Days
Class 1
Risk

About This 510(k) Submission

K946353 is an FDA 510(k) clearance for the EPSTEIN-BARR VIRUS NUCLEAR ANTIGEN RECOMBINANT IMMUNOFLUORESCENT ASSAY, a Test, Antigen, Nuclear, Epstein-barr Virus (Class I — General Controls, product code LLM), submitted by Mrl Diagnostics (Cypress, US). The FDA issued a Cleared decision on July 21, 1995, 203 days after receiving the submission on December 30, 1994. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K946353 FDA.gov
FDA Decision Cleared SESE
Date Received December 30, 1994
Decision Date July 21, 1995
Days to Decision 203 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LLM — Test, Antigen, Nuclear, Epstein-barr Virus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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