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510(k) K152025

Device
AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)
Applicant
ASSURE TECH. CO., LTD.
510(k) number
K152025
Product code
DJR  
Decision
Substantially Equivalent (SESE)
Decision date
2015-10-05
Date received
2015-07-22
Regulation
862.3620
Classification name
Enzyme Immunoassay, Methadone
Medical specialty
Toxicology
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ERIC LIN
Address
2nd. Floor, Bldg. 1, #10, Xiyuansan Rd. Hangzhou CN 310030 310030

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DJR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K192433LZI Methadone II Enzyme ImmunoassayLin-Zhi International, Inc.2019-10-04
K182779ARK EDDP AssayArk Diagnostics, Inc.2018-11-21
K170416LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) CalibratorsLin-Zhi International, Inc.2017-06-26
K160793First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)W.H.P.M., Inc.2016-08-17
K151395Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators, Immunalysis EDDP Urine Control SetsImmunalysis Corporation2015-07-24
K151441First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestW.H.P.M., Inc.2015-06-29
K131232WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)Guangzhou Wondfo Biotech Co., Ltd.2013-05-31
K092272RANDOX METHADONE ASSAYRandox Laboratories, Ltd.2010-11-18
K092258RANDOX METABOLITE (EDDP) ASSAYRandox Laboratories, Ltd.2010-11-09
K092048ONE STEP EDDP (METHADONE METABOLITE) TEST STRIPBiosite Incorporated2010-04-19
K081378DRI METHADONE METABOLITE (100/300) ASSAY, CALIBRATORS AND CONTROLSThermo Fisher Scientific2009-01-14
K062637VITROS CHEMISTRY PRODUCTS METD REAGENT, CALIBRATOR KIT 26, DAT PERFORMANCE, VERIFIERS I, II, III, IV & VOrtho-Clinical Diagnostics, Inc.2006-11-22
K060791TRIAGE TOX DRUG SCREEN, MODEL 94400Biosite Incorporated2006-06-22
K052197FIRST SIGN DRUG OF ABUSE URINE SCREENING TESTW.H.P.M., Inc.2006-06-09
K051058METHADONE ORAL FLUID HOMOGENEOUS ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLSLin-Zhi International, Inc.2006-03-29

Legacy Summary#

summary

FDA Review#

Decision Summary