Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

DHC — Predicate Candidate Screening

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

43 daysmedian FDA review time

331 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K001352	REAADS IGG ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT	Corgenix, Inc.	2001-04-09	346
K001398	REAADS IGM ANTI-PROTHROMBIN SEMI-QUANTITATIVE TEST KIT	Corgenix, Inc.	2001-03-30	331
K930247	HUMAN A-DS DNA EIA KIT FOR DIAGNOSTIC USE	The Binding Site, Ltd.	1993-03-10	50
K930421	ELIAS DSDNA ABS	Elias U.S.A., Inc.	1993-03-10	43
K914801	IMMUNOWELL DSDNA ANTIBODY TEST	General Biometrics, Inc.	1991-12-09	46
K885048	ACCESS R-CLONE ANA PROFILE ASSAY	Lipogen, Inc.	1989-01-24	48
K872910	IMMUNO/SLE	Immunostics Co., Inc.	1987-08-12	19
K821385	SERO/TEX LE TEST	Texas Immunology, Inc.	1982-05-28	18
K810981	ANTI NDNA IMMUNOFLOURESCENT TEST SYS	Immuno-Products Industries	1981-04-29	16
K810226	SLE ANTI-N-DNA LATEX TEST	Icl Scientific	1981-02-09	13
K800991	CORDIA N	Cordis Corp.	1980-05-08	14
K800992	CORDIA NP	Cordis Corp.	1980-05-08	14
K800605	ANA LATEX SLIDE TEST	Biologics Intl., Inc.	1980-04-02	16
K790106	IIF-A-N-DNA TEST KIT	Medica Corp.	1979-03-15	56
K790257	SYSTEMIC LUPUS	Icl Scientific	1979-03-15	37
K782129	LUPO-TEC	Armkel, LLC	1979-03-12	75

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