Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

DHN — Predicate Candidate Screening

110 FDA 510(k) clearances under this product code; the 50 most recent screened below.

37 daysmedian FDA review time

175 days90th percentile

110clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K201956	Zeus IFA ANA HEp-2 Test System, Zeus dIFine	Zeus Scientific, Inc.	2022-04-29	654	0
K172745	ImmuGlo HEp-2 Elite IFA	Immco Diagnostics, Inc.	2018-06-05	266	0
K153117	AESKUSLIDES ANA HEp-2-Gamma, HELIOS FULLY AUTOMATED IFA SYST	Aesku Systems GmbH&Co.Kg	2016-07-28	274	0
K160265	Image Navigator by Immuno Concepts	Immuno Concepts, N.A. , Ltd.	2016-06-17	136	0
K141827	EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFT	Euroimmun Us, Inc.	2015-04-17	284	0
K150155	NOVA Lite DAPI ANA Kit	Inova Diagnostics, Inc.	2015-04-08	75	0
K131791	IFA 40: HEP-20-10	Euroimmun US	2014-02-26	253	0
K120889	AESKUSLIDES ANA HEP-2	Aesku Diagnostics	2012-10-15	206	0
K070763	EUROIMMUN ANA IFA: HEP-20-10	Euroimmun Us, LLC	2007-05-22	63	0
K042680	RHIGENE HEP-ANA TEST SYSTEM	Corgenix, Inc.	2004-11-19	51	0
K024220	LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130	Bio-Rad	2003-01-17	25	0
K024222	LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG	Bio-Rad	2003-01-15	23	0
K024217	LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #	Bio-Rad	2003-01-15	23	0
K024224	LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129	Bio-Rad	2003-01-15	23	0
K024227	LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127	Bio-Rad	2003-01-15	23	0
K024225	LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119	Bio-Rad	2003-01-15	23	0
K024229	LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG	Bio-Rad	2003-01-15	23	0
K024230	LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED,	Bio-Rad	2003-01-15	23	0
K024221	LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE,	Bio-Rad	2003-01-15	23	0
K024231	LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CA	Bio-Rad	2003-01-13	21	0
K022800	VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM	Hyperion, Inc.	2002-11-25	94	0
K013213	HYPERION VISIQUANT ANA TEST KIT	Hyperion, Inc.	2002-06-04	251	0
K012163	POLYTITER SYSTEM	Polymedco, Inc.	2001-08-20	40	0
K001556	HEP-2 ANA TEST SYSTEM WITH IF-AIM TECHNOLOGY	The Binding Site, Ltd.	2000-08-21	95	0
K990915	INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG	Stellar Bio Systems, Inc.	1999-04-21	34	0
K983924	HEP-2000 COLORZYME ANA-RO TEST SYSTEM, MODEL 4200-RO	Immuno Concepts, Inc.	1998-12-18	44	0
K984400	LIQUICHEK ANA CONTROL, SPECKLED PATTERN, MODEL 202	Bio-Rad	1998-12-18	9	0
K984398	LIQUICHEK ANA CONTROL, HOMOGENEOUS PATTERN, MODEL 201	Bio-Rad	1998-12-18	9	0
K984397	LIQUICHEK ANA CONTROL, CENTROMERE PATTERN, MODEL 203	Bio-Rad	1998-12-18	9	0
K984399	LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, MODEL 204	Bio-Rad	1998-12-18	9	0
K972145	HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM	Immuno Concepts, Inc.	1998-02-24	263	0
K970198	IFA HEP2 KIT FOR THE DETECTION OF ANTINUCLEAR ANTIBODIES	Scimedx Corp.	1997-02-20	30	0
K964165	MICRO21 WITH NDNA	Triangle Biomedical Sciences, Inc.	1997-01-03	78	0
K962276	HEMAGEN ENA DSDNA KIT (EIA METHOD)	Hemagen Diagnostics, Inc.	1996-12-05	175	0
K950979	HEP-2000 COLORZYME ANA-RO TEST SYSTEM	Immuno Concepts, Inc.	1995-06-01	90	0
K944096	HEP-2000 FLUORESCENT ANA-RO TEST SYSTEM	Immuno Concepts, Inc.	1994-11-21	91	0
K926114	HEP-2 ANTINUCLEAR ANTIBODY TEST SYSTEM	Tissue Culture Biotec, Inc.	1993-05-20	168	0
K912292	DIASTAT ANTI-JO-1 KIT	Shield Diagnostics, Ltd.	1991-07-30	68	0
K902139	HEMAGEN ENA [JO-I] KIT	Hemagen Diagnostics, Inc.	1990-05-18	9	0
K901596	NOVA LITE(TM) ANA KSL	Inova Diagnostics, Inc.	1990-05-02	27	1
K901595	NOVA LITE(TM) ANA MK	Inova Diagnostics, Inc.	1990-04-26	21	0
K897025	ANTINUCLEAR ANTIBODY (ANA) TEST SYSTEM	Zeus Scientific, Inc.	1990-01-02	14	0
K894659	ANA ANTISERA CONTROL KIT	Lipogen, Inc.	1989-09-21	59	0
K884400	ANTI-NATIVE DNA ANTIBODY TEST (CRITHIDIA LUCILIAE)	Immco Diagnostics, Inc.	1988-11-04	16	0
K880742	NOVA LITE(TM) DSDNA	Inova Diagnostics, Inc.	1988-03-25	30	0
K874873	COMBIGENE(TM) ANTI-DNA #KADDZ, KADD1	Diagnostic Products Corp.	1988-02-10	72	0
K872845	BION ANTINUCLEAR ANTIBODY(ANA)TEST KIT/CONTR SERUM	Bion Ent., Ltd.	1987-08-17	28	0
K872560	ANTI-DNP MICROASSAY	Diamedix Corp.	1987-07-21	22	0
K871801	CYTOTECH ANTINUCLEAR ANTIBODY (ANA) IFA KIT	Cytotech, Inc.	1987-06-09	32	0
K871144	TANGENT SYSTEM(TM) ANA PROFILE TEST KIT	Vitrotec Laboratories, Inc.	1987-04-29	37	0

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda