Panels › Clinical Toxicology › Product code LFW · Class 2

Fluorescence Polarization Immunoassay, Tobramycin

Regulation 862.3900

0510(k)s in 12 months (10 all time)

0recalls in 12 months (2 all time)

2recalls that name a 510(k)

Top companies in LFW

Company	510(k)s	Recalls
Innotron of Oregon, Inc.	2	0
Microgenics Corp.	1	1
Roche Diagnostic Systems, Inc.	2	0
Abbott Laboratories	1	0
Colony Laboratories, Inc.	1	0
Innotron Diagnostics	1	0
Roche Diagnostics Corp.	0	1
Sigma Diagnostics, Inc.	1	0
Windsor Laboratories, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
Dec 16, 2013	Microgenics Corp Thermo Fisher Scientific/Microgenics brand CEDIA Tobramycin II Assay, Catalog Number 100018, Product is manufactured and distributed by Microgenics Corporation, located at Fremont, CA., part of Therm Terminated	LFW	K912143
Feb 28, 2006	Roche Diagnostics Corp. Roche brand CEDIA Tobramycin II Reagent, Catalog # 1815385, Material # 11815385216. Terminated	LFW	K912143

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