Cleared Special

MODIFICATION TO SERAQUEST VCA IGM

K033780 · Quest Intl., Inc. · Microbiology
Jan 2004
Decision
42d
Days
Class 1
Risk

About This 510(k) Submission

K033780 is an FDA 510(k) clearance for the MODIFICATION TO SERAQUEST VCA IGM, a Antibody Igm, If, Epstein-barr Virus (Class I — General Controls, product code LJN), submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on January 15, 2004, 42 days after receiving the submission on December 4, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K033780 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 2003
Decision Date January 15, 2004
Days to Decision 42 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LJN — Antibody Igm, If, Epstein-barr Virus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3235

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