Cleared Traditional

VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY

K920952 · Vitek Systems, Inc. · Immunology
Apr 1992
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K920952 is an FDA 510(k) clearance for the VITEK IMMUNODIAG ASSAY SYST(VIDAS) FERRITINE ASSAY, a Ferritin, Antigen, Antiserum, Control (Class II — Special Controls, product code DBF), submitted by Vitek Systems, Inc. (Hazelwood, US). The FDA issued a Cleared decision on April 7, 1992, 41 days after receiving the submission on February 26, 1992. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5340.

Submission Details

510(k) Number K920952 FDA.gov
FDA Decision Cleared SESE
Date Received February 26, 1992
Decision Date April 07, 1992
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

Device Classification

Product Code DBF — Ferritin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5340

Similar Devices — DBF Ferritin, Antigen, Antiserum, Control

All 86
LIAISON Ferritin
K193650 · DiaSorin, Inc. · Sep 2021
Yumizen C1200 Ferritin, Yumizen C1200 Transferrin, Yumizen C1200 Rheumatoid Factor
K191562 · HORIBA ABX SAS · Mar 2020
Atellica IM Ferritin Assay
K171642 · Siemens Healthcare Diagnostics, Inc. · Aug 2017
DIAZYME FERRITIN ASSAY, DIAZYME FERRITIN CALIBRATOR SET, DIAZYME FERRITIN CONTROL SET
K133083 · Diazyme Laboratories · Jun 2014
K-ASSAY (R) FERRITIN REAGENT, K-ASSAY (R) FERRITIN CALIBRATOR
K121232 · Kamiya Biomedical Company · May 2012
ADVIA CHEMISTRY FERRITIN (FRT) METHOD
K110736 · Siemens Healthcare Diagnostics, Inc. · Aug 2011