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

JNB — Predicate Candidate Screening

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

119 daysmedian FDA review time

797 days90th percentile

15clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K021541	NEOGRAM PKU TANDEM MASS SPECTROMETRY KIT	Perkinelmer Life Sciences	2002-10-28	171	1
K003584	NEOLYNX SCREENING APPLICATION MANAGER	Micromass, Inc.	2001-03-19	119	0
K000754	QUANTASE PHENYLALANINE SCREENING ASSAY 500 TEST KIT	Quantase , Ltd.	2000-06-19	103	1
K984463	QUANTASE PHE/GAL SCREENING ASSAY	Quantase , Ltd.	1999-02-16	62	0
K982307	WALLAC NEONATAL LEUCINE TEST KIT MODEL NL-1000	Wallac, Inc.	1999-02-02	216	0
K974047	ACCUWELL PHENYLALANINE ASSAY	Neometrics, Inc.	1997-12-05	42	0
K963040	MANUAL PHENYLALANINE TEST	Bio-Rad	1996-10-01	57	0
K960437	RADIAS PHENYLALANINE TEST	Bio-Rad	1996-08-16	198	0
K961515	QUANTASE PHENYLALANINE ASSAY	Shield Diagnostics, Ltd.	1996-06-12	63	1
K943547	PHENYLALANINE TEST KIT	Isolab, Inc.	1996-01-26	554	0
K926106	IMMUCHEM PHE-MW EA	Icn Biomedicals, Inc.	1995-02-08	797	0
K922547	QUANTASE PHENYLALANINE ASSAY	Porton Cambridge , Ltd.	1994-10-13	864	0
K891070	PHENYLALANINE (NINHYDRIN REACTION)	Alpkem Corp.	1989-10-27	240	0
K813449	PHE/TYR KINETIC UV TEST SET	P-L Biochemicals, Inc.	1981-12-31	21	0
K813171	PHENYLALANINE UV KINETIC TEST KIT	Biochemicals, Inc.	1981-12-03	17	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