Panels › Clinical Toxicology › Product code KLS · Class 2

Enzyme Immunoassay, Theophylline

Regulation 862.3880

0510(k)s in 12 months (71 all time)

0recalls in 12 months (8 all time)

8recalls that name a 510(k)

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Top companies in KLS

Company	510(k)s	Recalls
Syva Co.	11	0
Abbott Laboratories	7	0
Siemens Healthcare Diagnostics, Inc	0	5
E.I. Dupont DE Nemours & Co., Inc.	3	0
Ortho-Clinical Diagnostics, Inc.	1	2
Beckman Instruments, Inc.	2	0
Diagnostic Products Corp.	2	0
Electro-Nucleonics Laboratories, Inc.	2	0
Em Diagnostic Systems, Inc.	2	0
Immunotech Corp.	2	0

Decided	510(k)	Device and applicant	Code
Dec 11, 1984	K844170	THEOPHYLLINE RADIOIMMUNOASSAY ARIA HT SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic	KLS
May 22, 1984	K841656	DUPONT THEOPHYLLINE ASSAY KIT E.I. Dupont DE Nemours & Co., Inc.	KLS
Mar 19, 1984	K832825	SERALYZER THEOPHYLLINE REAGENT STRIPS Miles Laboratories, Inc.	KLS
Jan 30, 1984	K833989	VENTREZYME THEOPHYLLINE IMMUNOASSAY Vxr, Inc.	KLS
Jan 24, 1984	K834244	THEOFAST TEST KIT FOR QUANTITATIVE THEO Allergenetics	KLS
Dec 30, 1983	K832965	STRATUS THEOPHYLLINE ASSAY American Dade	KLS
Dec 27, 1983	K833683	CHEM KIT THEOPHYLLINE DIAG. KIT Abbott Laboratories	KLS
Sep 12, 1983	K831934	THEOPHYLLINE TEST PACK ACA E.I. Dupont DE Nemours & Co., Inc.	KLS
Aug 1, 1983	K832034	EMIT AAD THEOPHYLLINE ASSAY Syva Co.	KLS
May 27, 1983	K831272	EMIT QST THEOPHYLLINE ASSAY Syva Co.	KLS
Jun 10, 1982	K821544	DETECTION OF THEOPHYLLINE Electro-Nucleonics Laboratories, Inc.	KLS
May 13, 1982	K821154	KALLESTAD QUANTIZYME THEOPHYLLINE ENZYME Jay Rau, Technical Suppprt	KLS
Jul 27, 1981	K812003	A-GENT THEOPHYLLINE Abbott Laboratories	KLS
Mar 13, 1981	K810578	BECKMAN THEOPHYLLINE REAGENT TEST KIT Beckman Instruments, Inc.	KLS
Mar 6, 1981	K803094	COPPER SULFATE SOLUTION SP. GR.1.053 Accra Laboratories, Inc.	KLS
Oct 23, 1980	K802066	ENDAB THEOPHYLLINE ENZYME IMMUNOASSAY Immunotech Corp.	KLS
Aug 27, 1980	K801642	FIAX TEST KIT FOR THEOPHYLLINE QUANT. Intl. Diagnostic Technology	KLS
Jul 8, 1980	K801476	APPLICATION OF EMIT THEOPHYLLINE ASSAY Syva Co.	KLS
Apr 10, 1980	K800646	AMES TDA THEOPHYL-LINE TEST Miles Laboratories, Inc.	KLS
Mar 2, 1979	K790256	EMIT THEOPHYLLINE ASSAY Syva Co.	KLS
Mar 27, 1978	K772017	IN VITRO THEOPHYLLINE RIA TEST Clinical Assays, Inc.	KLS

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