Panels › Clinical Toxicology › Product code LGQ · Class 2

Fluorescence Polarization Immunoassay, Phenobarbital

Regulation 862.3660

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

0recalls in 12 months (2 all time)

1recalls that name a 510(k)

Top companies in LGQ

Company	510(k)s	Recalls
Roche Diagnostic Systems, Inc.	3	0
Abbott Laboratories	2	0
Oxis Intl., Inc.	2	0
Abbott Laboratories Diagnostic Div	0	1
Abbott Laboratories HPD/ADD/GPRD	0	1
Colony Laboratories, Inc.	1	0
Innotron Diagnostics	1	0
Innotron of Oregon, Inc.	1	0
Sclavo, Inc.	1	0
Windsor Laboratories, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
Jul 20, 2004	Abbott Laboratories HPD/ADD/GPRD Package Insert for TDx/TDxFLx and TDxFLx Vancomycin Reagents, REF 9523, item number 69-5726/R4; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60064 Terminated	LGQ	K813218
Jul 20, 2004	Abbott Laboratories Diagnostic Div AEROSET Phenobarbital, LN 1E08-01 Terminated	LGQ	None listed

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