FDA.reportPublic FDA data

510(k) K920417

Device
Il Test Barbiturate, 35289
Applicant
INSTRUMENTATION LABORATORY CO.
510(k) number
K920417
Product code
DIS
Decision
Substantially Equivalent (SESE)
Decision date
1992-04-24
Date received
1992-01-31
Regulation
862.3150
Classification name
Enzyme Immunoassay, Barbiturate
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
GABRIEL J MURACA
Address
113 Hartwell Ave. P.O. Box 9113 Lexington MA US 02173 02173

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DIS#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K161714Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation2016-10-14
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K092268RANDOX BARITURATES ASSAYRandox Laboratories, Ltd.2011-05-25
K110515UCP DRUG SCREENING TEST CUPSUcp Biosciences, Inc.2011-04-20
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K062165VITROS CHEMISTRY PRODUCTS BARB REAGENT; CALIBRATOR KIT 26; FS CALIBRATOR 1; DAT PERFORMANCE VERIFIERSOrtho-Clinical Diagnostics2007-01-05
K050024ONE STEP MULTIPLE DRUGS OF ABUSE ASSAYSGuangzhou Wondfo Biotech Co., Ltd.2005-11-17
K050593ACON BAR II ONE STEP BARBITURATES TEST STRIP & DEVICEACON Laboratories, Inc.2005-05-06
K042975AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL IIAmeditech, Inc.2004-12-29
K043211ONLINE DAT BARBITURATES PLUSRoche Diagnostics Corp.2004-12-29