FDA.reportPublic FDA data

510(k) K822051

Device
Emit D.a.v. Methaqualone Assay
Applicant
SYVA CO.
510(k) number
K822051
Product code
KXS
Decision
Substantially Equivalent (SESE)
Decision date
1982-07-27
Date received
1982-07-13
Regulation
862.3630
Classification name
Radioimmunoassay, Methaqualone
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KXS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K011164MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229Syva Co., Dade Behring, Inc.2001-05-10
K993986SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129ULSyva Co.2000-01-27
K955676SYNCHRON SYSTEMS METHAQUALONE REAGENTBeckman Instruments, Inc.1996-03-04
K945187ROCHE ABUSCREEN ONLINE FOR METHAQUALONERoche Diagnostic Systems, Inc.1995-04-05
K940123METHAQUALONE ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.1994-05-03
K921013SYVA EMIT II METHAQUALONE ASSAYSyva Co.1992-05-13
K874272REVISED LABELING FOR METHAQUALONE TEST KITRoche Diagnostic Systems, Inc.1987-11-13
K874199REVISED LABELING FOR SYVA METHAQUALONE ASSAYSSyva Co.1987-10-28
K873759LABELING CHANGE COAT-A-COUNT METHAQUALONEDiagnostic Products Corp.1987-10-15
K870935COAT-A-COUNT METHAQUALONE TKMQ1Diagnostic Products Corp.1987-03-19
K843605EMIT 700 METHAQUALONE ASSAYSyva Co.1984-10-05
K840164EMIT ST URINE METHAQUALONE ASSAYSyva Co.1984-03-22
K830461ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONEHoffmann-La Roche, Inc.1983-03-24
K821768EMIT ST URINE METHAGUALONE ASSAYSyva Co.1982-06-24
K812987AGGLUTEX METHAQUALONE TEST KITHoffmann-La Roche, Inc.1981-12-22