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510(k) K000447

Device
QUICKSCREEN METHAMPHETAMINE TEST, MODELS 9045, 9046, QUICKSCREEN PRO MULTI DRUG SCREENING TEST, MODEL 9225
Applicant
PHAMATECH
510(k) number
K000447
Product code
LAF  
Decision
Substantially Equivalent (SESE)
Decision date
2000-03-07
Date received
2000-02-10
Regulation
862.3610
Classification name
Gas Chromatography, Methamphetamine
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
CARL A MONGIOVI
Address
9265 Activity Rd., #112-113 San Diego CA US 92126 92126

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LAF  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K203647SEFRIA Methamphetamine Oral Fluid Enzyme ImmunoassayImmunalysis Corporation2021-12-22
K210212Psychemedics Homogeneous Enzyme Immunoassay for Amphetamines in HairPsychemedics Corporation2021-12-15
K201442Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay for Pictus AnalyzersDiatron Group2020-07-31
K170222Rapid Tox Cup IIAmerican Bio Medica Corp.2017-08-15
K153693Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsImmunalysis Corporation2016-03-18
K142293Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Oral Fluid Methamphetamine Calibrators, Rapidfret Oral Fluid Methamphetamine ControlsBiophor Diagnostics, Inc.2015-09-18
K150096Healgen MDMA (Ecstacy) Test (Strip, Cassette, Cup, Dip Card), Healgen Phencyclidine Test (Strip, Cassette, Cup, Dip Card)Healgen Scientific,, LLC2015-03-04
K150162First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestW.H.P.M., Inc.2015-02-26
K133047RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLUBiophor Diagnostics, Inc.2014-12-18
K131652LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLSLin-Zhi International, Inc.2014-03-21
K111927PSYCHEMEDICS METHAMPHETAMINE EIAPsychemedics Corp.2012-05-01
K113661LZI METHAMPHETAMINE ENZYME MMUNOASSAY, LZI METHAMPHETAMINE CALIBRATORS, LZI METHAMPHETAMINE CONTROLSLin-Zhi International, Inc.2012-01-23
K112236WONDFO METHYLENEDIOXYMETHAMPHETAMINE URINE TEST, WONDFO MORPHINE URINE TESTGuangzhou Wondfo Biotech Co., Ltd.2011-09-19
K101973OMEGA LABORATORIES HAIR DRUG SCREENING ASSAY FOR METHAMPHETAMINE AND 4-METHYLENEDIOXYMETHAMPHETAMINE (MDMA)Omega Laboratories, Inc.2011-08-16
K101753THERMO SCIENTIFIC CEDIA METHAMPHETAMINE OFT ASSAYMicrogenics Corp.2011-04-08

Legacy Summary#

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FDA Review#

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