Cleared Traditional

DIASORIN LIAISON VZV IGG

K061820 · DiaSorin, Inc. · Microbiology
Feb 2007
Decision
243d
Days
Class 2
Risk

About This 510(k) Submission

K061820 is an FDA 510(k) clearance for the DIASORIN LIAISON VZV IGG, a Enzyme Linked Immunoabsorbent Assay, Varicella-zoster (Class II — Special Controls, product code LFY), submitted by DiaSorin, Inc. (Stillwater, US). The FDA issued a Cleared decision on February 26, 2007, 243 days after receiving the submission on June 28, 2006. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3900.

Submission Details

510(k) Number K061820 FDA.gov
FDA Decision Cleared SESE
Date Received June 28, 2006
Decision Date February 26, 2007
Days to Decision 243 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LFY — Enzyme Linked Immunoabsorbent Assay, Varicella-zoster
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3900

Similar Devices — LFY Enzyme Linked Immunoabsorbent Assay, Varicella-zoster

All 16
LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
K231214 · DiaSorin, Inc. · Oct 2023
LIAISON VZV IgG, LIAISON Control VZV IgG
K150375 · DiaSorin, Inc. · Mar 2015
ZEUS SCIENTIFIC, INC VZV IGM ELISA TEST SYSTEM
K070317 · Zeus Scientific, Inc. · Jul 2007
ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM.
K051484 · Zeus Scientific, Inc. · Dec 2005
THE APTUS (AUTOMATED) APPLICATION OF THE VZV IGG ELISA TEST SYSTEM
K984181 · Zeus Scientific, Inc. · Jan 1999
IS-VZU IGG TEST SYSTEM
K981867 · Diamedix Corp. · Sep 1998