Cleared Traditional

IMMUNOWELL EA (D) IGG TEST

K010301 · Genbio · Microbiology
Jun 2001
Decision
130d
Days
Class 1
Risk

About This 510(k) Submission

K010301 is an FDA 510(k) clearance for the IMMUNOWELL EA (D) 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 June 11, 2001, 130 days after receiving the submission on February 1, 2001. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K010301 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2001
Decision Date June 11, 2001
Days to Decision 130 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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