ClearanceBrief
Panels › Immunology › Product code DHN · Class 2

Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control

Regulation 866.5100

0510(k)s in 12 months (110 all time)
0recalls in 12 months (7 all time)
7recalls that name a 510(k)
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Top companies in DHN

Company510(k)sRecalls
Bio-Rad140
Immuno Concepts, Inc.71
Zeus Scientific, Inc.60
Inova Diagnostics, Inc.41
Meloy Laboratories, Inc.50
Euroimmun US30
Amico Lab, Inc.20
Apple Diagnostic Products20
Behring Diagnostics, Inc.20
Bio-Rad Laboratories02
Decided510(k)Device and applicantCode
Apr 29, 2022K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFine
Zeus Scientific, Inc.
DHN
Jun 5, 2018K172745ImmuGlo HEp-2 Elite IFA
Immco Diagnostics, Inc.
DHN
Jul 28, 2016K153117AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM
Aesku Systems GmbH&Co.Kg, DE
DHN
Jun 17, 2016K160265Image Navigator by Immuno Concepts
Immuno Concepts, N.A. , Ltd.
DHN
Apr 17, 2015K141827EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE
Euroimmun Us, Inc.
DHN
Apr 8, 2015K150155NOVA Lite DAPI ANA Kit
Inova Diagnostics, Inc.
DHN
Feb 26, 2014K131791IFA 40: HEP-20-10
Euroimmun US
DHN
Oct 15, 2012K120889AESKUSLIDES ANA HEP-2
Aesku Diagnostics
DHN
May 22, 2007K070763EUROIMMUN ANA IFA: HEP-20-10
Euroimmun Us, LLC
DHN
Nov 19, 2004K042680RHIGENE HEP-ANA TEST SYSTEM
Corgenix, Inc.
DHN
Jan 17, 2003K024220LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130
Bio-Rad
DHN
Jan 15, 2003K024230LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131
Bio-Rad
DHN
Jan 15, 2003K024229LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111
Bio-Rad
DHN
Jan 15, 2003K024227LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127
Bio-Rad
DHN
Jan 15, 2003K024225LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119
Bio-Rad
DHN
Jan 15, 2003K024224LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129
Bio-Rad
DHN
Jan 15, 2003K024222LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112
Bio-Rad
DHN
Jan 15, 2003K024221LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118
Bio-Rad
DHN
Jan 15, 2003K024217LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108
Bio-Rad
DHN
Jan 13, 2003K024231LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118
Bio-Rad
DHN
Nov 25, 2002K022800VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM
Hyperion, Inc.
DHN
Jun 4, 2002K013213HYPERION VISIQUANT ANA TEST KIT
Hyperion, Inc.
DHN
Aug 20, 2001K012163POLYTITER SYSTEM
Polymedco, Inc.
DHN
Aug 21, 2000K001556HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY
The Binding Site, Ltd.
DHN
Apr 21, 1999K990915INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY
Stellar Bio Systems, Inc.
DHN
Dec 18, 1998K984400LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202
Bio-Rad
DHN
Dec 18, 1998K984399LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204
Bio-Rad
DHN
Dec 18, 1998K984398LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201
Bio-Rad
DHN
Dec 18, 1998K984397LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203
Bio-Rad
DHN
Dec 18, 1998K983924HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO
Immuno Concepts, Inc.
DHN
Feb 24, 1998K972145HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
Immuno Concepts, Inc.
DHN
Feb 20, 1997K970198IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES
Scimedx Corp.
DHN
Jan 3, 1997K964165MICRO21 WITH NDNA
Triangle Biomedical Sciences, Inc.
DHN
Dec 5, 1996K962276HEMAGEN ENA DSDNA KIT (EIA METHOD)
Hemagen Diagnostics, Inc.
DHN
Jun 1, 1995K950979HEP-2000 COLORZYME ANA-RO TEST SYSTEM
Immuno Concepts, Inc.
DHN
Nov 21, 1994K944096HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM
Immuno Concepts, Inc.
DHN
May 20, 1993K926114HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM
Tissue Culture Biotec, Inc.
DHN
Jul 30, 1991K912292DIASTAT ANTI-JO-1 KIT
Shield Diagnostics, Ltd., GB
DHN
May 18, 1990K902139HEMAGEN ENA [JO-I] KIT
Hemagen Diagnostics, Inc.
DHN
May 2, 1990K901596NOVA LITE(TM) ANA KSL
Inova Diagnostics, Inc.
DHN
Apr 26, 1990K901595NOVA LITE(TM) ANA MK
Inova Diagnostics, Inc.
DHN
Jan 2, 1990K897025ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM
Zeus Scientific, Inc.
DHN
Sep 21, 1989K894659ANA ANTISERA CONTROL KIT
Lipogen, Inc.
DHN
Nov 4, 1988K884400ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)
Immco Diagnostics, Inc.
DHN
Mar 25, 1988K880742NOVA LITE(TM) DSDNA
Inova Diagnostics, Inc.
DHN
Feb 10, 1988K874873COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1
Diagnostic Products Corp.
DHN
Aug 17, 1987K872845BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM
Bion Ent., Ltd.
DHN
Jul 21, 1987K872560ANTI-DNP MICROASSAY
Diamedix Corp.
DHN
Jun 9, 1987K871801CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT
Cytotech, Inc.
DHN
Apr 29, 1987K871144TANGENT SYSTEM(TM) ANA PROFILE TEST KIT
Vitrotec Laboratories, Inc.
DHN

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