Panels › Clinical Toxicology › Product code LAS · Class 1

Drug Specific Control Materials

Regulation 862.3280

0510(k)s in 12 months (83 all time)

0recalls in 12 months (1 all time)

1recalls that name a 510(k)

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Top companies in LAS

Company	510(k)s	Recalls
Syva Co.	22	0
Roche Diagnostic Systems, Inc.	14	0
Utak Laboratories, Inc.	8	0
Hemometrix	6	0
Microgenics Corp.	5	0
E.I. Dupont DE Nemours & Co., Inc.	3	0
Bio-Rad	2	0
Consolidated Technologies, Inc.	2	0
More Diagnostics	2	0
Sigma Diagnostics, Inc.	2	0

Decided	510(k)	Device and applicant	Code
Jun 16, 1983	K831417	EMIT QST TOBRAMYCIN CONTROL Syva Co.	LAS
Jan 28, 1983	K830049	ADVANCE EMIT-CAD DISOPYRAMIDE CONTROL Syva Co.	LAS
Dec 15, 1982	K823369	ADVANCE EMIT(R) & TM AMIKACIN CONTROL Syva Co.	LAS
Oct 27, 1982	K822934	SYVA ADVANCE EMIT AED VALPROIC ACID CONT Syva Co.	LAS
Jun 24, 1982	K821766	EMIT - ST URINE METHAGUALONE CONTROLS Syva Co.	LAS
Jun 2, 1982	K821380	EMIT TOX ACETAMINOPHEN CONTROL Syva Co.	LAS
Mar 11, 1982	K820439	EMIT-AMD AMIKACIN CONTROL Syva Co.	LAS
Mar 4, 1982	K820392	*ORTHO BI-LEVEL ASSAYED ALCOHOL DILUEN** Ortho Diagnostic Systems, Inc.	LAS
Feb 23, 1982	K820323	EMIT AND NETILMICIN CONTROL Syva Co.	LAS
Feb 23, 1982	K820286	SYVA ADVANCE SY. EMIT-AMD GENT. CONTROL Syva Co.	LAS
Jan 29, 1982	K820129	ADVANCE SYSTEM EMIT-AMD TOBRAMYCIN CNTRL Syva Co.	LAS
Dec 3, 1981	K813241	EMIT-AAD THEOPHYLLINE CONTROL Syva Co.	LAS
Aug 20, 1981	K812196	EMIT-ST CANNABINOID CONTROLS Syva Co.	LAS
Jun 25, 1981	K811619	EMIT-ST SERUM PHENOBARBITAL CONTROLS Syva Co.	LAS
Jun 9, 1981	K811462	EMIT-CAD QUINDINE CONTROL Syva Co.	LAS
Feb 4, 1981	K810201	TOXICOLOGY CONTROL Utak Laboratories, Inc.	LAS
Dec 22, 1980	K803107	AMES TDA AMIKACIN CONTROL SERUM Miles Laboratories, Inc.	LAS
Jun 17, 1980	K801206	EMIT VALPROIC ACID CONTROL Syva Co.	LAS
Jun 9, 1980	K801205	EMIT DISOPYRAMIDE CONTROL Syva Co.	LAS
Apr 16, 1980	K800357	BI-LEVEL ASSAYED CARD. DRUG CONT., I,II Ortho Diagnostics, Inc.	LAS
Dec 18, 1979	K792264	TOBRAMYCIN LIQUID CONTROL SERUM Hemometrix	LAS
Dec 18, 1979	K792263	TOBRAMYCIN CONTROL SERUM Hemometrix	LAS
Dec 18, 1979	K792262	GENTAMICIN LIQUID CONTROL SERUM Hemometrix	LAS
Dec 18, 1979	K792261	GENTAMICIN CONTROL SERUM Hemometrix	LAS
Dec 18, 1979	K792260	AMIKACIN LIQUID CONTROL SERUM Hemometrix	LAS
Dec 18, 1979	K792259	AMIKACIN CONTROL SERUM Hemometrix	LAS
May 15, 1979	K790830	EMIT GENTAMICIN CONTROL Syva Co.	LAS
Mar 15, 1979	K790402	EMIT-QUINIDINE CONTROL Syva Co.	LAS
Jan 10, 1979	K782084	EMIT PROCAINAMIDE CONTROL SET Syva Co.	LAS
Jan 3, 1979	K781827	CONTROL SET, EMIT METHOTREXATE Syva Co.	LAS
Dec 7, 1978	K780961	THEOPHYLLINE CONTROL SERUM Vitek Systems, Inc.	LAS
Feb 3, 1978	K780142	ANTICONVULSANT CONTROL SERUM Mcdonnell Douglas Corp.	LAS
Oct 7, 1976	K760730	ANTICONVULSANT CONTROL SERUM Bio-Reagents & Diagnostics, Inc.	LAS

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