FDA 510(k) Applications for Medical Device Product Code "DHN"
(Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K120889 | AESKU DIAGNOSTICS | AESKUSLIDES ANA HEP-2 | 10/15/2012 |
| K153117 | AESKU. SYSTEMS GMBH & CO. KG | AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYSTEM | 07/28/2016 |
| K024222 | BIO-RAD | LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 | 01/15/2003 |
| K024221 | BIO-RAD | LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 | 01/15/2003 |
| K024230 | BIO-RAD | LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131 | 01/15/2003 |
| K984397 | BIO-RAD | LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203 | 12/18/1998 |
| K984398 | BIO-RAD | LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201 | 12/18/1998 |
| K984399 | BIO-RAD | LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204 | 12/18/1998 |
| K024229 | BIO-RAD | LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111 | 01/15/2003 |
| K984400 | BIO-RAD | LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202 | 12/18/1998 |
| K024217 | BIO-RAD | LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108 | 01/15/2003 |
| K024227 | BIO-RAD | LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 | 01/15/2003 |
| K024231 | BIO-RAD | LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118 | 01/13/2003 |
| K024225 | BIO-RAD | LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 | 01/15/2003 |
| K024224 | BIO-RAD | LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 | 01/15/2003 |
| K024220 | BIO-RAD | LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 | 01/17/2003 |
| K042680 | CORGENIX, INC. | RHIGENE HEP-ANA TEST SYSTEM | 11/19/2004 |
| K141827 | EUROIMMUN U.S., Inc. | EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE | 04/17/2015 |
| K131791 | EUROIMMUN US | IFA 40: HEP-20-10 | 02/26/2014 |
| K070763 | EUROIMMUN US LLC | EUROIMMUN ANA IFA: HEP-20-10 | 05/22/2007 |
| K962276 | HEMAGEN DIAGNOSTICS, INC. | HEMAGEN ENA DSDNA KIT (EIA METHOD) | 12/05/1996 |
| K013213 | HYPERION, INC. | HYPERION VISIQUANT ANA TEST KIT | 06/04/2002 |
| K022800 | HYPERION, INC. | VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM | 11/25/2002 |
| K172745 | IMMCO Diagnostics, Inc. | ImmuGlo HEp-2 Elite IFA | 06/05/2018 |
| K983924 | IMMUNO CONCEPTS, INC. | HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO | 12/18/1998 |
| K972145 | IMMUNO CONCEPTS, INC. | HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM | 02/24/1998 |
| K160265 | Immuno Concepts, NA, Ltd. | Image Navigator by Immuno Concepts | 06/17/2016 |
| K150155 | INOVA DIAGNOSTICS, INC. | NOVA Lite DAPI ANA Kit | 04/08/2015 |
| K012163 | POLYMEDCO, INC. | POLYTITER SYSTEM | 08/20/2001 |
| K970198 | SCIMEDX CORP. | IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES | 02/20/1997 |
| K990915 | STELLAR BIO SYSTEMS, INC. | INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY | 04/21/1999 |
| K001556 | THE BINDING SITE, LTD. | HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY | 08/21/2000 |
| K964165 | TRIANGLE BIOMEDICAL SCIENCES, INC. | MICRO21 WITH NDNA | 01/03/1997 |
| K201956 | Zeus Scientific, Inc. | Zeus IFA ANA HEp-2 Test System, Zeus dIFine | 04/29/2022 |
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