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

DBI — Predicate Candidate Screening

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

45 daysmedian FDA review time

198 days90th percentile

34clearances measured

K-number	Device	Applicant	Decided	Review days
K100455	SPAPLUS ANALYZER	The Binding Site	2010-09-03	198
K012359	TINA-QUANT COMPLEMENT C4 TEST SYSTEM	Roche Diagnostics Corp.	2001-11-29	127
K010325	WAKO AUTOKIT C4	Wako Chemicals USA, Inc.	2001-06-25	143
K000468	RANDOX COMPLEMENT C4	Randox Laboratories, Ltd.	2000-03-27	45
K994293	DIMENSION C4 FLEX REAGENT CARTRIDGE	Dade Behring, Inc.	2000-03-01	71
K981785	C4 MININEPH ANTISERUM	The Binding Site, Ltd.	1999-12-20	579
K993481	K-ASSAY C4	Kamiya Biomedical Co.	1999-11-29	46
K983356	C4	Abbott Laboratories	1998-11-04	41
K964297	N-ASSAY TIA C4 TEST KIT	Crestat Diagnostics, Inc.	1997-07-14	258
K964300	N-ASSAY TIA MULTI V-NL	Crestat Diagnostics, Inc.	1997-07-14	258
K962582	OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT	Olympus America, Inc.	1996-10-18	109
K962198	QUANTEX C4	Instrumentation Laboratory CO	1996-09-26	111
K920010	IL TEST COMPLEMENT 4	Instrumentation Laboratory CO	1992-03-13	71
K911899	RAICHEM SPIA C4 REAGENT	Reagents Applications, Inc.	1991-05-09	13
K892129	EZ COMPLEMENT C4	Diamedix Corp.	1989-04-14	18
K890564	SPQ(TM) ANTIBODY REAGENT SET II FOR C4	Atlantic Antibodies	1989-02-17	24
K882621	COMPLEMENT C4 FOR THE TECHNICON DPA-1(TM) SYSTEM	Technicon Instruments Corp.	1988-07-08	14
K872599	QM300 C4 ANTIBODY PACK	Kallestad Diag, A Div. of Erbamont, Inc.	1987-07-23	21
K871023	PRECIMAT(R) C4	Boehringer Mannheim Corp.	1987-05-14	59
K870931	TINA-QUANT(R) (A) C4	Boehringer Mannheim Corp.	1987-03-24	15
K855012	QUANTIMETRIC PLUS C4 REAGENT KIT	Kallestad Laboratories, Inc.	1986-02-26	72
K853468	GILFORD C4 COMPLEMENT REAGENT	Gilford	1985-09-16	28
K850585	SPQ TEST SYSTEM FOR COMPLEMENT C4	Applications Lab	1985-03-01	16
K834605	C4 ANTIGEN ANTIBODY CONTROL	Technicon Instruments Corp.	1984-01-24	116
K831906	RABBIT ANTISERUM TO HUMAN C4	Dako Corp.	1983-07-19	35
K830669	FIAX COMPLEMENT C4 TEST KIT	Intl. Diagnostic Technology	1983-04-08	35
K812490	IMMUNOGL. FRCT. OF RABBIT ANTISER.-C4	Dako Corp.	1981-09-23	23
K810502	SCRIPPSYSTEM C4 RID KIT	Scripps-Miles, Inc.	1981-04-08	43
K802196	GOAT ANTI-HUMAN COMPLEMENT C4	Protos Laboratories	1980-10-31	51
K801361	COMPLEMENT C4 NEPHELOMETRIC ASSAY	J.T. Baker Chemical Co.	1980-06-30	21
K772073	RADIAL IMMUNODIFFUSION KIT-COMP. 3	Gelman Instrument Co.	1978-02-03	92
K772247	COMPLEMENT C4 NEPHELOMETRIC ASSAY	Kallestad Laboratories, Inc.	1977-12-22	13
K772004	HUMAN C4 COMPLEMENT CONTROL SERUM	G.D. Searle and Co.	1977-11-03	13
K772002	PLATES FOR HUMAN C4 COMPLEMENT	G.D. Searle and Co.	1977-11-02	12

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