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LAS — Drug Specific Control Materials Class I

FDA Device Classification

Classification Details

Product Code
LAS
Device Class
Class I
Regulation Number
862.3280
Submission Type
Review Panel
TX
Medical Specialty
Clinical Toxicology
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K080459chromsystems instruments and chemicalsCHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLSNovember 17, 2009
K072257more diagnosticsMYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELJanuary 30, 2008
K062942quantimetrixQUANTIMETRIX NICOSURE COTININE URINE CONTROLOctober 30, 2006
K051074microgenicsMAS IMMUNOSUPPRESSANT CONTROLSJune 6, 2005
K040411microgenicsDRI OXYCODONE ASSAYMay 27, 2004
K032842microgenicsMICROGENICS CYCLOSPORINE CONTROL KITOctober 17, 2003
K030616microgenicsCEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5March 31, 2003
K992151consolidated technologiesREFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINEJuly 14, 1999
K970517oxis intlINNOFLUOR TOPIRAMATE CONTROL SETMay 12, 1997
K971210beckman instrumentsSYNCHRON SYSTEMS 10 NG/ML & 40 NG/ML THC URINE CONTROLSApril 17, 1997
K946119roche diagnostic systemsROCHE-TDM ONLEIN(TM) CONTROLSFebruary 7, 1995
K943048microgenicsMICROGENICS THC CONTROL SETSAugust 24, 1994
K930844roche diagnostic systemsROCHE ABUSCREEN ONTRAK POS. REF. CONTROL-METHADONEJanuary 27, 1994
K934145e.i. dupont de nemours and coDUPONT ACA URINE METHADONE CONTROLNovember 9, 1993
K933557consolidated technologiesREFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINESeptember 10, 1993
K932662more diagnosticsCYCLOSPORINE (WHOLE BLOOD) CONTROL-PEDIATRIC LEVELJuly 26, 1993
K921939heraeus kulzerSERALYZER(R) THERAPEUTIC DRUG ASSAY CONTROL(ABNOR)July 16, 1992
K921141diagnostic reagentsCANNABINOID URINE CONTROLSApril 17, 1992
K915516roche diagnostic systemsABUSCREEN ONLINE CANNABINOIDS POSITIVE CONTROLJanuary 28, 1992
K913677analytical control systemsACS THERAPEUTIC DRUG MONIT CONTOLS, LEVEL I,II,IIISeptember 25, 1991