Cleared Traditional

SERAQUEST EB VAC IGM

K990977 · Quest Intl., Inc. · Microbiology
Oct 1999
Decision
197d
Days
Class 1
Risk

About This 510(k) Submission

K990977 is an FDA 510(k) clearance for the SERAQUEST EB VAC 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 October 6, 1999, 197 days after receiving the submission on March 23, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K990977 FDA.gov
FDA Decision Cleared SESE
Date Received March 23, 1999
Decision Date October 06, 1999
Days to Decision 197 days
Submission Type Traditional
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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