Cleared Traditional

IMMUNOWELL EBNA IGG TEST

K973941 · Genbio · Microbiology
Aug 1998
Decision
299d
Days
Class 1
Risk

About This 510(k) Submission

K973941 is an FDA 510(k) clearance for the IMMUNOWELL EBNA IGG TEST, a Test, Antigen, Nuclear, Epstein-barr Virus (Class I — General Controls, product code LLM), submitted by Genbio (San Diego, US). The FDA issued a Cleared decision on August 10, 1998, 299 days after receiving the submission on October 15, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K973941 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1997
Decision Date August 10, 1998
Days to Decision 299 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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