Cleared Traditional

IMMUNOWELL EBV VCA IGG TEST

K973940 · Genbio · Microbiology
Aug 1998
Decision
299d
Days
Class 1
Risk

About This 510(k) Submission

K973940 is an FDA 510(k) clearance for the IMMUNOWELL EBV VCA IGG 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 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 K973940 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 LSE — Epstein-barr Virus, Other
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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