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

Neogenex — Predicate Candidate Screening

20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

111 daysmedian FDA review time

231 days90th percentile

20clearances measured

K-number	Device	Applicant	Decided	Review days
K965047	MINK LUNG CELL CULTURE	Neogenex	1997-02-04	48
K960909	H292 CELL CULTURE	Neogenex	1996-05-30	86
K943887	HUMAN NEWBORN FORESKIN CELL CULTURE	Neogenex	1994-11-28	111
K943891	RD CULTURE CELL	Neogenex	1994-11-28	111
K943885	PRIMARY RABBIT KIDNEY CELL CULTURE	Neogenex	1994-11-28	111
K943889	VERO CELL CULTURE	Neogenex	1994-11-28	111
K943884	PRIMARY MONKEY KIDNEY CELL CULTURE	Neogenex	1994-11-28	111
K943890	WI38 CELL CULTURE	Neogenex	1994-11-28	111
K943888	MDCK CELL CULTURE	Neogenex	1994-11-28	111
K943886	BGM CELL CULTURE	Neogenex	1994-11-28	111
K941714	CHLAMYDIA TRACHOMATIS ANTIGEN TEST	Neogenex	1994-07-18	117
K942172	INFLUENZA A ANTIGEN TEST	Neogenex	1994-07-06	62
K942174	INFLUENZA B ANITGEN TEST	Neogenex	1994-06-30	56
K942173	RSV ANTIGEN TEST	Neogenex	1994-06-30	56
K942171	CMV EARLY ANTIGEN TEST	Neogenex	1994-06-30	56
K933927	HEP-2 CULTURE CELL	Neogenex	1994-03-31	233
K933923	A549 CULTURE CELL	Neogenex	1994-03-29	231
K933924	MCCOY CULTURE CELL	Neogenex	1994-03-29	231
K933925	MRC-5 CULTURE CELL	Neogenex	1994-03-29	231
K933926	LLCMK2 CULTURE CELLS	Neogenex	1994-03-29	231

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