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510(k) K201442

Device
Lin-Zhi International, Inc. (LZI) Methamphetamine Enzyme Immunoassay For Pictus Analyzers
Applicant
Diatron Group
510(k) number
K201442
Product code
LAF  
Decision
Substantially Equivalent (SESE)
Decision date
2020-07-31
Date received
2020-06-01
Regulation
862.3610
Classification name
Gas Chromatography, Methamphetamine
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Frank Matuszak
Address
12601 NW 115th Ave. Suite A113 Medley FL US 33178 33178

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
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
K093884ROCHE FLUDI METHAMPHETAMINERoche Diagnostics2011-02-25

Legacy Summary#

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FDA Review#

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