Cleared Special

MODIFICATION TO SERAQUEST EB VCA IGG

K033915 · Quest Intl., Inc. · Microbiology
Jan 2004
Decision
29d
Days
Class 1
Risk

About This 510(k) Submission

K033915 is an FDA 510(k) clearance for the MODIFICATION TO SERAQUEST EB VCA IGG, a Epstein-barr Virus, Other (Class I — General Controls, product code LSE), submitted by Quest Intl., Inc. (North Miami, US). The FDA issued a Cleared decision on January 16, 2004, 29 days after receiving the submission on December 18, 2003. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K033915 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2003
Decision Date January 16, 2004
Days to Decision 29 days
Submission Type Special
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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