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510(k) K831739

Device
PENTOBARBITAL TOXICOLOGY CONTROL
Applicant
UTAK LABORATORIES, INC.
510(k) number
K831739
Product code
LAS  
Decision
Substantially Equivalent (SESE)
Decision date
1983-07-06
Date received
1983-05-31
Regulation
862.3280
Classification name
Drug Specific Control Materials
Medical specialty
Toxicology
Review panel
Toxicology
Device class
1
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 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
K062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLQuantimetrix Corp.2006-10-30
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

Legacy Summary#

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FDA Review#

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