Cleared Traditional

(EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM

K901840 · Granbio, Inc. · Microbiology
Sep 1990
Decision
141d
Days
Class 1
Risk

About This 510(k) Submission

K901840 is an FDA 510(k) clearance for the (EIA) FOR IGM ANTIBODY TO EBV VCA IN HUMAN SERUM, a Antibody Igm, If, Epstein-barr Virus (Class I — General Controls, product code LJN), submitted by Granbio, Inc. (Temecula, US). The FDA issued a Cleared decision on September 12, 1990, 141 days after receiving the submission on April 24, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3235.

Submission Details

510(k) Number K901840 FDA.gov
FDA Decision Cleared SESE
Date Received April 24, 1990
Decision Date September 12, 1990
Days to Decision 141 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

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

Similar Devices — LJN Antibody Igm, If, Epstein-barr Virus

All 22
BIOPLEX 2200 EBV IGM KIT
K123021 · Bio-Rad Laboratories · Nov 2012
PLEXUS EBV IGM MULTI-ANALYTE DIAGNOSTICS, MODEL: MP0600M
K073381 · Focus Diagnostics, Inc. · Aug 2008
ATHENA MULTI-LYTE EBV VCA IGM TEST SYSTEM
K042092 · Zeus Scientific, Inc. · Apr 2005
MODIFICATION TO SERAQUEST VCA IGM
K033780 · Quest Intl., Inc. · Jan 2004
SERAQUEST EB VAC IGM
K990977 · Quest Intl., Inc. · Oct 1999
COPALIS EBV-M ANTIBODY ASSAY
K991459 · DiaSorin, Inc. · May 1999