Panels › Clinical Toxicology › Product code DKZ · Class 2
Enzyme Immunoassay, Amphetamine
Regulation 862.3100
0510(k)s in 12 months (225 all time)
0recalls in 12 months (24 all time)
20recalls that name a 510(k)
Top companies in DKZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 26, 2022 | Mckesson Medical-Surgical Inc. Corporate Office Drugs of Abuse Tests:
a. Wondfo Tdip Drugs of Abuse Test Tdip Single Drug Fentanyl (FEN) Urine Sample 25 Tests. Model Number: AWFTY-114.
b. Alere Drugs of Abuse Test E-Z Split Key Cup 12-Drug P Open, Classified |
DKZ | K133968 K182701 |
| Aug 18, 2020 | Ameditech Inc First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B Terminated |
DKZ | K052115 |
| Aug 18, 2020 | Ameditech Inc First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B Terminated |
DKZ | K052115 |
| Aug 18, 2020 | Ameditech Inc First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B Terminated |
DKZ | K052115 |
| Nov 14, 2017 | Alere San Diego, Inc. Triage Drugs of Abuse Plus TCA 25 Test Kit, Model Numbers 92000, 92590, 92591; 25 individually pouched devices, 1 bottle of
Wash Solution, 1 Pipette and 50 Pipette Tips in a labeled kit box.
Product Completed |
DKZ | K973784 |
| Oct 16, 2014 | Ameditech Inc ArcPoint Labs 10 Panel Dip Screen (OXY), Part No. APD-10MO.
The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites i Terminated |
DKZ | K113046 |
| Oct 16, 2014 | Ameditech Inc ArcPoint Labs 10 Panel Dip Screen (BAR), Part No. APD-10M.
The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in Terminated |
DKZ | K113046 |
| Oct 16, 2014 | Ameditech Inc ArcPoint Labs 5 Panel Dip Drug Screen, Part No. APD-5M.
The ArcPoint Labs Dip Drug Screen Dip Card is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in hu Terminated |
DKZ | K113046 |
| Jan 9, 2014 | Alere San Diego, Inc. Product Brand Name(s):
Innovacon Oral Fluid Drug Screen Device,
OrALert Oral Fluid Drug Screen Device,
OrALert Oral Fluid Drug Screen Device with BZO,
Reditest On-Site Oral Fluid Drug Screen Devic Terminated |
DKZ | None listed |
| Aug 23, 2013 | Sarken, Inc. SARKEN STAT! 1- Panel Test Kit-mAMP
Product Usage:
Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing). Terminated |
DKZ | None listed |
| Aug 23, 2013 | Sarken, Inc. SARKEN STAT! Multi-Drug Test Panel
Product Usage- Labeled as FOR FORENSIC USE ONLY (Employee, Student or Probation Testing). Terminated |
DKZ | None listed |
| Jan 11, 2012 | Alere San Diego Triage Drugs of Abuse Panel Plus TCA 25 Test Kit, PN (Model Number) 92000
An immunoassay used for the qualitative determination of the presence of the major metabolites of drugs of abuse and Tricycli Terminated |
DKZ | K973784 |
| Nov 3, 2011 | Ameditech Inc ProScreen PSCup-5M Waived, Catalog Number: PSCup-5M Waived
Product Usage: The ProScreen Drugs of Abuse Test Cup is a one-step immunoassay for the qualitative detection of multiple drugs in human uri Terminated |
DKZ | K052115 |
| Jul 27, 2011 | Alere San Diego Calloway LabsMulti-Drug 9 Panel Assay
A rapid, one step screening test for the simultaneous for the qualitative detection of multiple drugs and drug metabolites in human urine. Terminated |
DKZ | K061718 |
| Jun 27, 2011 | Ameditech Inc SCREENERS Dip Drug Test, Catalog Number: SCD-7MB300
The SCREENERS Dip Drug Test is a one-step immunoassay for the qualitative detection of multiple drugs and drug metabolites in human urine at a give Terminated |
DKZ | K042975 K050186 |
| Oct 6, 2009 | Biosite Inc Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUE-187-071-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG Terminated |
DKZ | K061718 |
| Oct 6, 2009 | Biosite Inc Multi-Drug iCup Drug Screen Test Cup. Part Number DUE-1127-022-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG Terminated |
DKZ | K061718 |
| Oct 6, 2009 | Biosite Inc Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-197-014-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG Terminated |
DKZ | K061718 |
| Oct 6, 2009 | Biosite Inc Multi-Drug 8 Panel Integrated iCup Drug Screen Test Cup. Part Number DUD-187-013-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG Terminated |
DKZ | K061718 |
| Oct 6, 2009 | Biosite Inc Multi-Drug iCup Drug Screen Test Cup. Part Number DUD-1107-012-08A.
Subsequent Product Codes: DIO, DIS, DJC, DJG, DJR, JXM, JXN, LCM, LDJ, LFG Terminated |
DKZ | K061718 |
| Mar 17, 2009 | Biosite Inc Triage Drugs of Abuse Panel, Model Number: 95000.
Is an immunoassay test kit used for the qualitative determination of the presence of the major metabolites of drugs of abuse in urine. Terminated |
DKZ | K973784 |
| Sep 26, 2008 | Medtox Diagnostics Inc MEDTOXscan Reader Terminated |
DKZ | None listed |
| May 14, 2008 | Abbott Laboratories AxSYM Drugs of Abuse/Toxicology Assay Disk Version 8.0; List Number: 3D54-08; Abbott La boratories, Diagnostics Division, Abbott Park, IL 60064 Terminated |
DKZ | K953115 |
| Apr 10, 2007 | Bio-Rad Laboratories Inc Bio-Rad-TOX/See Drug Screen Test (25 tests/box), Catalog number 194-5230; Product is distributed by Bio-Rad Laboratories, Inc., Hercules, CA Terminated |
DKZ | K031759 |
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