Panels › Clinical Toxicology › Product code LCE · Class 2

Radioimmunoassay, Netilmicin (I-125)

Regulation 862.3450

0510(k)s in 12 months (6 all time)

0recalls in 12 months (0 all time)

0recalls that name a 510(k)

Top companies in LCE

Company	510(k)s	Recalls
Syva Co.	2	0
Abbott Laboratories	1	0
American Diagnostic Corp.	1	0
Bd Becton Dickinson Vacutainer Systems Preanalytic	1	0
Miles Laboratories, Inc.	1	0

Decided	510(k)	Device and applicant	Code
Dec 27, 1983	K833715	EMIT NETILMICIN ASSAY Syva Co.	LCE
Oct 28, 1983	K832088	AMES TDA NETILMICIN TEST & SERUM Miles Laboratories, Inc.	LCE
Oct 26, 1982	K822941	NETILMICIN FLUORESCENT IMMUNOASSAY American Diagnostic Corp.	LCE
Jun 22, 1982	K821698	TDX NETILMICIN Abbott Laboratories	LCE
May 28, 1982	K821399	MACRO-VUE CARD TEST, NETILMICIN Bd Becton Dickinson Vacutainer Systems Preanalytic	LCE
Feb 23, 1982	K820324	EMIT AND NETILMICIN ASSAY Syva Co.	LCE

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