Cleared Traditional

IMMUNODOT MONO-G TEST

K974226 · Genbio · Microbiology
Sep 1998
Decision
314d
Days
Class 1
Risk

About This 510(k) Submission

K974226 is an FDA 510(k) clearance for the IMMUNODOT MONO-G TEST, a Epstein-barr Virus, Other (Class I — General Controls, product code LSE), submitted by Genbio (San Diego, US). The FDA issued a Cleared decision on September 22, 1998, 314 days after receiving the submission on November 12, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K974226 FDA.gov
FDA Decision Cleared SESE
Date Received November 12, 1997
Decision Date September 22, 1998
Days to Decision 314 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LSE — Epstein-barr Virus, Other
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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