DHN · Class II · 21 CFR 866.5100

FDA Product Code DHN: Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Leading manufacturers include Bio-Rad, Immuno Concepts, Inc. and Zeus Scientific, Inc..

110
Total
110
Cleared
67d
Avg days
1976
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control Devices (Product Code DHN)

110 devices
1–24 of 110
Cleared Apr 29, 2022
Zeus IFA ANA HEp-2 Test System, Zeus dIFine
K201956
Zeus Scientific, Inc.
Immunology · 654d
Cleared Jun 05, 2018
ImmuGlo HEp-2 Elite IFA
K172745
Immco Diagnostics, Inc.
Immunology · 266d
Cleared Jul 28, 2016
AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
K153117
Aesku Systems GmbH&Co.Kg
Immunology · 274d
Cleared Jun 17, 2016
Image Navigator by Immuno Concepts
K160265
Immuno Concepts, N.A. , Ltd.
Immunology · 136d
Cleared Apr 17, 2015
EUROIMMUN IFA 40: HEP-20-10
K141827
Euroimmun Us, Inc.
Immunology · 284d
Cleared Apr 08, 2015
NOVA Lite DAPI ANA Kit
K150155
Inova Diagnostics, Inc.
Immunology · 75d
Cleared Feb 26, 2014
IFA 40: HEP-20-10
K131791
Euroimmun US
Immunology · 253d
Cleared Oct 15, 2012
AESKUSLIDES ANA HEP-2
K120889
Aesku Diagnostics
Immunology · 206d
Cleared May 22, 2007
EUROIMMUN ANA IFA: HEP-20-10
K070763
Euroimmun Us, LLC
Immunology · 63d
Cleared Nov 19, 2004
RHIGENE HEP-ANA TEST SYSTEM
K042680
Corgenix, Inc.
Immunology · 51d
Cleared Jan 17, 2003
LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130
K024220
Bio-Rad
Immunology · 25d
Cleared Jan 15, 2003
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108
K024217
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118
K024221
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112
K024222
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129
K024224
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119
K024225
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127
K024227
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111
K024229
Bio-Rad
Immunology · 23d
Cleared Jan 15, 2003
LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131
K024230
Bio-Rad
Immunology · 23d
Cleared Jan 13, 2003
LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118
K024231
Bio-Rad
Immunology · 21d
Cleared Nov 25, 2002
VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM
K022800
Hyperion, Inc.
Immunology · 94d
Cleared Jun 04, 2002
HYPERION VISIQUANT ANA TEST KIT
K013213
Hyperion, Inc.
Immunology · 251d
Cleared Aug 20, 2001
POLYTITER SYSTEM
K012163
Polymedco, Inc.
Immunology · 40d
Cleared Aug 21, 2000
HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY
K001556
The Binding Site, Ltd.
Immunology · 95d

About Product Code DHN - Regulatory Context

510(k) Submission Activity

110 total 510(k) submissions under product code DHN since 1976, with 110 receiving FDA clearance (average review time: 67 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.