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

DDB — Predicate Candidate Screening

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

57 daysmedian FDA review time

252 days90th percentile

19clearances measured

K-number	Device	Applicant	Decided	Review days
K161508	Ceruloplasmin	Beckman Coulter Ireland, Inc.	2017-01-09	222
K122965	HUMAN CAERULOPLASMIN KIT	The Binding Site Group , Ltd.	2013-06-03	252
K053074	N ANTISERA TO HUMAN CERULOPLASMIN	Dade Behring, Inc.	2006-03-16	135
K964762	IMMAGE IMMUNOCHEMISTRY SYSTEM CERULOPLASMIN (CER) REAGENT	Beckman Instruments, Inc.	1997-04-25	149
K913668	CAERULOPLASMIN IMMUNOLOGICAL NL TEST KIT	The Binding Site, Ltd.	1991-12-20	123
K895377	QM300 CERULOPLASMIN ANTIBODY PACK	Kallestad Diag, A Div. of Erbamont, Inc.	1989-09-21	22
K860138	NO. 615 DETERMINATION OF CERULOPLASMIN IN SERUM	Sigma Diagnostics, Inc.	1986-03-28	73
K850682	72 DETERM. SIZE RADIAL IMMUNO. TEST HUMAN CERULOPL	Kent Laboratories, Inc.	1985-11-25	277
K852247	LASER CERULOPLASMIN KIT(CERULOPLASMIN REAGENTS)	Behring Diagnostics, Inc.	1985-07-10	48
K851283	RADIAL IMMUNODIFFUSION PLATES-CERULOPLASMIN	Cooper Biomedical, Inc.	1985-05-23	52
K823107	QUANTIMETRIC 2 CERULOPLASMIN ASSAY	Kallestad Laboratories, Inc.	1982-11-16	26
K812486	IMMUNOGL. FRCT. OF RABBIT ANTISER.-CERUL	Dako Corp.	1981-09-23	23
K801661	J.T. BAKER CERULOPLASMIN NEPHELOMETRIC	J.T. Baker Chemical Co.	1980-09-16	57
K790712	ANTISERUM TO HUMAN, ALPHA-2-MACROGLOBULI	Kent Laboratories, Inc.	1979-08-16	126
K791339	HUMAN CERULOPLASMIN	Beckman Instruments, Inc.	1979-08-16	31
K790714	ANTISERUM TO HUMAN CERULOPLASMIN	Kent Laboratories, Inc.	1979-08-16	126
K781024	CERUOPLASMIN SERUM ANTI-HUMAN	Icl Scientific	1978-08-14	56
K772255	CERULOPLASMIN NEPHEL. ASSAY	Kallestad Laboratories, Inc.	1978-01-05	27
K771795	LAS-R CERULOPLASMIN TEST	Hyland Therapeutic Div., Travenol Laboratories	1977-11-14	52

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