Company · US

Neogenex

FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 1997. Name variants (Inc, Corp, punctuation) are merged.

20510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
KIR	Cells, Animal And Human, Cultured	15
GNW	Antisera, Cf, Influenza Virus A, B, C	2
GQI	Antiserum, Cf, Cytomegalovirus	1
LJP	Antiserum, Fluorescent, Chlamydia Trachomatis	1
LKT	Respiratory Syncytial Virus, Antigen, Antibody, Ifa	1

Decided	510(k)	Device and applicant	Code
Feb 4, 1997	K965047	MINK LUNG CELL CULTURE Neogenex	KIR
May 30, 1996	K960909	H292 CELL CULTURE Neogenex	KIR
Nov 28, 1994	K943891	RD CULTURE CELL Neogenex	KIR
Nov 28, 1994	K943890	WI38 CELL CULTURE Neogenex	KIR
Nov 28, 1994	K943889	VERO CELL CULTURE Neogenex	KIR
Nov 28, 1994	K943888	MDCK CELL CULTURE Neogenex	KIR
Nov 28, 1994	K943887	HUMAN NEWBORN FORESKIN CELL CULTURE Neogenex	KIR
Nov 28, 1994	K943886	BGM CELL CULTURE Neogenex	KIR
Nov 28, 1994	K943885	PRIMARY RABBIT KIDNEY CELL CULTURE Neogenex	KIR
Nov 28, 1994	K943884	PRIMARY MONKEY KIDNEY CELL CULTURE Neogenex	KIR
Jul 18, 1994	K941714	CHLAMYDIA TRACHOMATIS ANTIGEN TEST Neogenex	LJP
Jul 6, 1994	K942172	INFLUENZA A ANTIGEN TEST Neogenex	GNW
Jun 30, 1994	K942174	INFLUENZA B ANITGEN TEST Neogenex	GNW
Jun 30, 1994	K942173	RSV ANTIGEN TEST Neogenex	LKT
Jun 30, 1994	K942171	CMV EARLY ANTIGEN TEST Neogenex	GQI
Mar 31, 1994	K933927	HEP-2 CULTURE CELL Neogenex	KIR
Mar 29, 1994	K933926	LLCMK2 CULTURE CELLS Neogenex	KIR
Mar 29, 1994	K933925	MRC-5 CULTURE CELL Neogenex	KIR
Mar 29, 1994	K933924	MCCOY CULTURE CELL Neogenex	KIR
Mar 29, 1994	K933923	A549 CULTURE CELL Neogenex	KIR

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.