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510(k) K121065

Device
POLYMED THERAPEUTICS FASTEP DIPSTICK DRUGS OF ABUSE SCREEN DEVICE AND DIPCARD DRUGS OF ABUSE SCREEN DEVICE
Applicant
POLYMED THERAPEUTICS, INC
510(k) number
K121065
Product code
DKZ  
Decision
Substantially Equivalent (SESE)
Decision date
2013-05-24
Date received
2012-04-06
Regulation
862.3100
Classification name
Enzyme Immunoassay, Amphetamine
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JJ XIA
Address
12828 Doe Ln. Gaithersburg MD US 20878 20878

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DKZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K240670DRI Ecstasy Plus AssayMicrogenics Corporation2024-10-30
K233019AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel RxHangzhou AllTest Biotech Co., Ltd.2023-12-13
K231137Xenta Drug Screen Cup, Xenta Drug Screen DipcardXenta Biomedical Science Co., Ltd.2023-05-19
K200363Quidel Triage® TOX Drug Screen, 94600Quidel Cardiovascular, Inc.2020-03-11
K191099Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelAtlas Medical2019-10-03
K182719Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProQuidel Cardiovascular, Inc.2019-06-19
K182738Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug Rapid Test Panel (Urine), Single and Multi-Drug Rapid Test Cup With Adulteration (Urine), Single and Multi-Drug Rapid Test Cup (Urine), Single Drug Rapid Test Dipstick (Urine), Single and Multi-Drug Home Rapid Test Panel (Urine), Single and Multi-Drug Home Rapid Test Cup (Urine), Single Drug Home Rapid Test Dipstick (Urine)Hangzhou AllTest Biotech Co., Ltd.2019-03-27
K180879BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug Test Easy Cup for Rx Use, BIO-VENTURE Rapid Multi-Drug Test Split Key Cup for Rx UseShanghai Venture Bio-Tech Co., Ltd.2018-12-14
K181945QuickScreen Pro Multi Drug Screening Test, Model 9395ZPhamatech, Inc.2018-10-18
K173303INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use)Alfa Scientific Designs, Inc.2018-02-23
K161251CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam TestsHangzhou Clongene Biotech Co., Ltd.2016-08-30
K152122Instant-View Multi-Drug Urine Test Cup (Home Use), Instant-View Multi-Drug Urine Test Panel (Home Use)Alfa Scientific Designs, Inc.2016-06-24
K152908UCP COMPACT DRUG TESTSUcp Biosciences, Inc.2016-05-03
K152590ACCU NEWS Drug Screening Test Card/Urine CupCoretests, Inc.2016-04-15
K153465AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup)Assure Tech. (Hangzhou) Co, Ltd.2016-03-31

Legacy Summary#

summary

FDA Review#

Decision Summary