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

JZJ — Predicate Candidate Screening

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

51 daysmedian FDA review time

253 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K000661	RANDOX PREALBUMIN	Randox Laboratories, Ltd.	2000-04-13	45
K972638	TINA-QUANT PREALBUMIN	Boehringer Mannheim Corp.	1998-01-09	178
K951966	HUMAN PREALBUMIN RADIAL IMMUNODIFFUSION KIT	Kent Laboratories, Inc.	1995-06-01	35
K913672	PREALBUMIN IMMUNOLOGICAL NL TEST KIT	The Binding Site, Ltd.	1991-12-20	123
K884298	SPQ(TM) TEST SYSTEM FOR MICROALBUMIN	Atlantic Antibodies	1988-11-02	21
K884297	SPQ(TM) TEST SYSTEM FOR PREALBUMIN	Atlantic Antibodies	1988-11-02	21
K883002	QM300 PREALBUMIN ANTIBODY PACK	Kallestad Diag, A Div. of Erbamont, Inc.	1988-09-22	66
K850686	ANTISERUM TO HUMAN PREALBUMIN	Kent Laboratories, Inc.	1985-11-01	253
K851912	LASER PREALBUMIN TEST	Behring Diagnostics, Inc.	1985-06-21	51
K821135	PREALBUMIN ENZYME IMMUNOASSAY	Abbott Laboratories	1983-05-05	380
K772329	LAS-R HUMAN PREALBUMIN TEST	Hyland Therapeutic Div., Travenol Laboratories	1978-02-03	44

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