Cleared Traditional

EBNA IGG EIA TEST SYSTEM

K951549 · Immunoprobe, Inc. · Microbiology
Apr 1996
Decision
391d
Days
Class 1
Risk

About This 510(k) Submission

K951549 is an FDA 510(k) clearance for the EBNA IGG EIA TEST SYSTEM, a Test, Antigen, Nuclear, Epstein-barr Virus (Class I — General Controls, product code LLM), submitted by Immunoprobe, Inc. (Washington, US). The FDA issued a Cleared decision on April 29, 1996, 391 days after receiving the submission on April 4, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K951549 FDA.gov
FDA Decision Cleared SESE
Date Received April 04, 1995
Decision Date April 29, 1996
Days to Decision 391 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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