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

DAK — Predicate Candidate Screening

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

55 daysmedian FDA review time

275 days90th percentile

28clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K031563	BINDAZYME CLQ CIC EIA KIT	The Binding Site, Ltd.	2003-09-10	114	1
K032254	IBL C1Q-CIC CIA TEST	Ibl GmbH	2003-08-29	38	0
K012576	CIC-C1Q EIA	American Laboratory Products Co., Ltd.	2002-01-29	173	0
K973203	THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-	Sangstat Medical Corp.	1998-09-30	400	0
K972873	IMMUSTRIP HAMA IGG	Immunomedics, Inc.	1998-03-17	225	0
K951968	HUMAN C1Q RADIAL IMMUNODIFFUSION KIT	Kent Laboratories, Inc.	1995-05-30	33	0
K914388	C1 RID KIT	The Binding Site, Ltd.	1991-10-28	27	0
K882829	CIRCULATING IMMUNE COMPLEXES CONTROLS	Cytotech, Inc.	1988-08-04	27	0
K860996	SANASSAY IC TEST	Scientific Sales Intl., Inc.	1987-03-30	384	0
K864312	IC MICROASSAY	Diamedix Corp.	1987-01-09	67	0
K862649	CYTOTECH CIC ENZYME IMMUNOASSAY	Cytotech, Inc.	1986-09-04	55	0
K861499	BIOSTAR* READS* IMMUNE COMPLEX ASSAY KIT	Biostar Medical Products, Inc.	1986-06-20	58	0
K853697	BIOSTAR RE-A-DS IMMUNE COMPLEX ASSAY KIT	Biostar Medical Products, Inc.	1985-12-16	103	0
K851202	GILFORD TRI-LEVEL ASSAYED IMMUNOLOGY CONTROL	Gilford	1985-04-29	34	0
K844294	CORDIA IC	Cordis Corp.	1985-02-04	90	0
K833275	GMP CIQ ELISA TEST KIT	Gamma Medical Products, Inc.	1984-06-22	275	0
K833636	ORTHO* SERUM ELISA TEST SYSTEM	Ortho Diagnostic Systems, Inc.	1984-06-13	240	0
K841541	SERUM COMPLEMENT ACTIVITY TEST-SCAT	Collaborative Research, Inc.	1984-06-01	46	0
K823009	GAMMA CLQ	Gamma Medical Products, Inc.	1982-11-05	24	0
K821949	ORTHO* ALTERNATIVE PATHWAY COMPL. TEST	Ortho Diagnostic Systems, Inc.	1982-08-27	58	0
K821806	ORTHO CLG IMMUNE COMPLEX TEST SYSTEM	Ortho Diagnostic Systems, Inc.	1982-06-25	8	0
K792472	ELECTRO-IMMUNO-QUANTITATION (EIQ)	Icl Scientific	1979-12-27	24	0
K781022	ANTI-HUMAN CIQ SERUM	Icl Scientific	1978-08-14	56	0
K780729	LAS-R HUMAN COMPLEMENT CLQ TEST	Hyland Therapeutic Div., Travenol Laboratories	1978-05-18	16	0
K772114	FIAX C4 ASSAY	Idt, A Division of Whittaker M.A. Bioproducts	1977-11-30	23	0
K772003	HUMAN REFERENCE SERUM C4 COMPLEMENT	G.D. Searle and Co.	1977-11-03	13	0
K770964	GOAT ANTISERUM COMPLEMENT C3 NEPHEL.	Kallestad Laboratories, Inc.	1977-06-24	28	0
K770547	LAS-R TM HUMAN COMPLEMENT C4 TEST	Hyland Therapeutic Div., Travenol Laboratories	1977-05-03	43	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