Panels › Clinical Toxicology › Product code KLQ · Class 2

Radioimmunoassay, Amikacin

Regulation 862.3035

0510(k)s in 12 months (20 all time)

0recalls in 12 months (0 all time)

0recalls that name a 510(k)

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Top companies in KLQ

Company	510(k)s	Recalls
Diagnostic Products Corp.	2	0
Miles Laboratories, Inc.	2	0
Abbott Laboratories	1	0
American Dade	1	0
American Diagnostic Corp.	1	0
Antibodies, Inc.	1	0
Bd Becton Dickinson Vacutainer Systems Preanalytic	1	0
Colony Laboratories, Inc.	1	0
Dade Behring, Inc.	1	0
E.I. Dupont DE Nemours & Co., Inc.	1	0

Decided	510(k)	Device and applicant	Code
Nov 1, 2005	K052815	QMS AMIKACIN REAGENTS Seradyn, Inc.	KLQ
Jun 9, 2004	K033884	RANDOX AMIKACIN Randox Laboratories, Ltd., GB	KLQ
Feb 9, 1996	K955570	INNOFLUOR AMIKACIN ASSAY SYSTEM Oxis Intl., Inc.	KLQ
Aug 9, 1990	K903100	INNOFLUOR (TM) AMIKACIN REAGENT SET Innotron of Oregon, Inc.	KLQ
Sep 28, 1989	K894517	FPR AMIKACIN KIT Colony Laboratories, Inc.	KLQ
Jun 25, 1985	K852317	COBAS FP REAGEN FOR AMIKACIN & AMIKACIN CALIBRATOR Roche Diagnostic Systems, Inc.	KLQ
Sep 12, 1984	K843211	AMIKACIN ANALYTICAL TEST PACK ACA E.I. Dupont DE Nemours & Co., Inc.	KLQ
May 2, 1984	K841161	IMMPULSE AMIKACIN ASSAY REAGENTS Paragon Diagnostics, Inc.	KLQ
Mar 23, 1984	K840193	EMIT QST AMIKACIN ASSAY Syva Co.	KLQ
Aug 31, 1983	K832336	STRATUS AMIKACIN FLUOROMETRIC American Dade	KLQ
Sep 28, 1982	K822657	EMIT-AMD AMIKACIN ASSAY Dade Behring, Inc.	KLQ
Jun 25, 1982	K821771	MACRO-VUE CARD TEST, AMIKACIN Bd Becton Dickinson Vacutainer Systems Preanalytic	KLQ
Apr 9, 1982	K820781	COAT-A-COUNT AMIKACIN IRA Diagnostic Products Corp.	KLQ
Jan 12, 1982	K813541	AMIKACIN FLUORESCENT IMMUNOASSAY American Diagnostic Corp.	KLQ
Apr 29, 1981	K811026	AMES TDA TM AMIKACIN TEST Miles Laboratories, Inc.	KLQ
Dec 19, 1980	K802877	AMIKACIN RIA KIT Antibodies, Inc.	KLQ
Nov 12, 1980	K802669	CYBREX AMIKACIN Abbott Laboratories	KLQ
May 28, 1980	K801130	AMES TDA AMIKACIN Miles Laboratories, Inc.	KLQ
Mar 20, 1980	K800517	TOBRAM E.R.A. TM P-L Biochemicals, Inc.	KLQ
Apr 10, 1978	K780494	AMIKACIN Diagnostic Products Corp.	KLQ

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