Cleared Traditional

SERAQUEST EB NA IGG

K991975 · Quest Intl., Inc. · Microbiology
Nov 1999
Decision
144d
Days
Class 1
Risk

About This 510(k) Submission

K991975 is an FDA 510(k) clearance for the SERAQUEST EB NA 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 November 2, 1999, 144 days after receiving the submission on June 11, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K991975 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 1999
Decision Date November 02, 1999
Days to Decision 144 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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