Cleared Traditional

VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG)

K902925 · Vitek Systems, Inc. · Microbiology
Aug 1990
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K902925 is an FDA 510(k) clearance for the VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS) (RBG), a Enzyme Linked Immunoabsorbent Assay, Rubella (Class II — Special Controls, product code LFX), submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on August 9, 1990, 37 days after receiving the submission on July 3, 1990. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3510.

Submission Details

510(k) Number K902925 FDA.gov
FDA Decision Cleared SESE
Date Received July 03, 1990
Decision Date August 09, 1990
Days to Decision 37 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code LFX — Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3510

Similar Devices — LFX Enzyme Linked Immunoabsorbent Assay, Rubella

All 93
Access Rubella IgG
K250588 · Beckman Coulter, Inc. · Nov 2025
Alinity i Rubella IgG
K243168 · Abbott Laboratories · Jun 2025
LIAISON RUBELLA IGM, LIAISON CONTROL RUBELLA IGM
K122397 · DiaSorin, Inc. · Sep 2012
MAGO 4S
K093101 · Diamedix Corp. · Jan 2011
BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM
K092587 · Bio-Rad Laboratories · Dec 2010
ELECSYS RUBELLA IGM IMMUNOASSAY
K092322 · Roche Diagnostics · Mar 2010