FDA.report

510(k) K133047

Device
RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU
Applicant
Biophor Diagnostics, Inc.
510(k) number
K133047
Product code
LAF
Decision
Substantially Equivalent (SESE)
Decision date
2014-12-18
Date received
2013-09-27
Regulation
862.3610
Classification name
Gas Chromatography, Methamphetamine
Medical specialty
Clinical Toxicology
Review panel
Clinical Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Nathaniel G Butlin
Address
1201 Douglas Ave. Redwood City CA US 94063 94063

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code LAF

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
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