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

CJW — Predicate Candidate Screening

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

52 daysmedian FDA review time

144 days90th percentile

18clearances measured

K-number	Device	Applicant	Decided	Review days
K203530	Albumin BCP2	Abbott Ireland Diagnostics Division	2022-03-18	471
K193001	Albumin BCP	SENTINEL CH. SpA	2019-12-19	52
K132664	ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY	Siemens Healthcare Diagnostics, Inc.	2013-10-16	50
K021636	ALBUMIN REAGENT	Intersect Systems, Inc.	2002-07-17	61
K000483	RANDOX ALBUMIN	Randox Laboratories, Ltd.	2000-03-31	46
K990978	ALBUMIN BCG, MODEL AL 103-01	A.P. Total Care, Inc.	1999-05-25	63
K981814	ALBP	Abbott Laboratories	1998-07-22	61
K981457	ALBP	Abbott Mfg., Inc.	1998-05-27	34
K913025	ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16	Em Diagnostic Systems, Inc.	1991-10-09	92
K905776	ALBUMIN REAGENT SET	Biochemical Trade, Inc.	1991-02-26	61
K863226	ALBUMIN (BCP)	Sigma Diagnostics, Inc.	1986-09-17	27
K863004	EMDS(TM) ALBUMIN TESTPACKS, #67652/95	Em Diagnostic Systems, Inc.	1986-09-16	39
K862138	VISION ALBUMIN	Abbott Laboratories	1986-06-17	13
K860423	A-GENT LIQUID ALBUMIN	Abbott Laboratories	1986-03-17	41
K844426	ALBUMIN BCP	Boehringer Mannheim Corp.	1985-01-07	53
K842847	WAKO AUTOMATED REAGENTS FOR HITACHI 705	Wako Chemicals USA, Inc.	1984-12-11	144
K832632	ALBUMIN PROCEDURE BCP	Sandare Chemical Co., Inc.	1983-09-12	39
K830934	QUANTIMETRIX BROMERESOL PURPLE ALBUMIN	Quantimetrix Corp.	1983-04-18	26

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