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 Apr 08, 2015
NOVA Lite DAPI ANA Kit
K150155
Inova Diagnostics, Inc.
Immunology · 75d
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 Aug 21, 2000
HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY
K001556
The Binding Site, Ltd.
Immunology · 95d
Cleared Dec 18, 1998
HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO
K983924
Immuno Concepts, Inc.
Immunology · 44d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203
K984397
Bio-Rad
Immunology · 9d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201
K984398
Bio-Rad
Immunology · 9d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204
K984399
Bio-Rad
Immunology · 9d
Cleared Dec 18, 1998
LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202
K984400
Bio-Rad
Immunology · 9d
Cleared Feb 24, 1998
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K972145
Immuno Concepts, Inc.
Immunology · 263d
Cleared Dec 05, 1996
HEMAGEN ENA DSDNA KIT (EIA METHOD)
K962276
Hemagen Diagnostics, Inc.
Immunology · 175d
Cleared Jun 01, 1995
HEP-2000 COLORZYME ANA-RO TEST SYSTEM
K950979
Immuno Concepts, Inc.
Immunology · 90d
Cleared Nov 21, 1994
HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
K944096
Immuno Concepts, Inc.
Microbiology · 91d
Cleared May 18, 1990
HEMAGEN ENA [JO-I] KIT
K902139
Hemagen Diagnostics, Inc.
Immunology · 9d

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.