Cleared Traditional

SERAQUEST EBV EA-D IGG TEST

K091260 · Quest Intl., Inc. · Microbiology
Jun 2009
Decision
40d
Days
Class 1
Risk

About This 510(k) Submission

K091260 is an FDA 510(k) clearance for the SERAQUEST EBV EA-D IGG TEST, a Epstein-barr Virus, Other (Class I — General Controls, product code LSE), submitted by Quest Intl., Inc. (Mami, US). The FDA issued a Cleared decision on June 8, 2009, 40 days after receiving the submission on April 29, 2009. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K091260 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2009
Decision Date June 08, 2009
Days to Decision 40 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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