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510(k) K062942

Device
QUANTIMETRIX NICOSURE COTININE URINE CONTROL
Applicant
Quantimetrix Corp.
510(k) number
K062942
Product code
LAS
Decision
Substantially Equivalent (SESE)
Decision date
2006-10-30
Date received
2006-09-28
Regulation
862.3280
Classification name
Drug Specific Control Materials
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
BERNICE NAVARRO
Address
2005 Manhattan Beach Blvd. Redondo Beach CA US 90278 90278

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LAS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K080459CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLSChromsystems Instruments & Chemicals GmbH2009-11-17
K072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELMore Diagnostics2008-01-30
K051074MAS IMMUNOSUPPRESSANT CONTROLSMicrogenics Corp.2005-06-06
K040411DRI OXYCODONE ASSAYMicrogenics Corp.2004-05-27
K032842MICROGENICS CYCLOSPORINE CONTROL KITMicrogenics Corp.2003-10-17
K030616CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5Microgenics Corp.2003-03-31
K992151REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINEConsolidated Technologies, Inc.1999-07-14
K970517INNOFLUOR TOPIRAMATE CONTROL SETOxis Intl., Inc.1997-05-12
K971210SYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLSBeckman Instruments, Inc.1997-04-17
K946119ROCHE-TDM ONLEIN(TM) CONTROLSRoche Diagnostic Systems, Inc.1995-02-07
K943048MICROGENICS THC CONTROL SETSMicrogenics Corp.1994-08-24
K930844ROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONERoche Diagnostic Systems, Inc.1994-01-27
K934145DUPONT ACA URINE METHADONE CONTROLE.I. Dupont DE Nemours & Co., Inc.1993-11-09
K933557REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINEConsolidated Technologies, Inc.1993-09-10
K932662CYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVELMore Diagnostics1993-07-26