FDA.reportPublic FDA data

510(k) K013410

Device
AT HOME DRUG TEST, MODEL 9064
Applicant
Phamatech, Inc.
510(k) number
K013410
Product code
MVO
Decision
Substantially Equivalent (SESE)
Decision date
2001-12-06
Date received
2001-10-15
Classification name
Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
CARL MONGIOVI
Address
9530 Padgett St., #101 San Diego CA US 92126 92126

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code MVO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K040327ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC)Accu-Stat Diagnostics, Inc.2004-04-19
K030447AT HOME DRUG CUP, MODEL 9150XPhamatech2003-04-14
K014192LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS METPrinceton BioMeditech Corp.2002-05-23
K013778PEACE OF MIND HOME DRUG TESTAdvantage Diagnostics Corp.2002-02-07
K013409AT HOME DRUG TEST, MODEL 9074Phamatech, Inc.2001-12-06
K013412AT HOME DRUG TEST, MODEL 9069Phamatech, Inc.2001-12-06
K010653AT HOME DRUG TEST, MODEL 9068 TPhamatech2001-04-05
K010654AT HOME DRUG TEST, MODEL 9078 TPhamatech2001-04-05
K010655AT HOME DRUG TESTT, MODEL 9150 TPhamatech2001-04-05
K010646AT HOME DRUG TEST, MODEL 9083 TPhamatech2001-03-30
K003858MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175Phamatech2001-02-12
K991465DRUG STOPTexas Immunology, Inc.1999-12-10
K992685QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25CPhamatech1999-10-06
K992217AT HOME DRUG TEST, MODEL 9175Phamatech1999-07-13
K991824AT HOME DRUG TEST, MODEL 9171Phamatech1999-06-11