Panels › Clinical Toxicology › Product code JXM · Class 2
Enzyme Immunoassay, Benzodiazepine
Regulation 862.3170
0510(k)s in 12 months (90 all time)
0recalls in 12 months (81 all time)
80recalls that name a 510(k)
Top companies in JXM
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 16, 2015 | Ameditech Inc DrugSmart 11 Test Cup, Item No. 61127D Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5 Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12, DCC-81205-5 Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc BZO Strip Dip Card (300ng/ml)*, Item No. 100170 Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc 6 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUP Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP, PSD-6MTDBO300, PSD-10PPX, PSD-10MOX, 60960D, 61127D, DCC-81205-5,
IMCA-10M5. Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc 11 Panel Card (OPI 300) w/Adult, Item No. 71125AA Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc 10-Panel Pipette Drug Screen, Item No. PSP-10M Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc 1 Step 12 Panel Cup, Item No. NBCA-12M-W Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU,
MTPA-8MBAU
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc The Drug Detection Agency 6 Panel Cup Body and Lid w/Adult (AU),
Item No. TDDA-6MBAU-CUP
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc ProScreen 10 Drug Panel Cassette Test, Item No. CPSP-10PPX;
ProScreen 10 Panel Cup, Item No. PSCup-10MMO-300, PSCup-10M,
PSCupA-10MO, PSCUp-10AB;
ProScreen 10 Panel Cup with Adulterants, Item No. PSCu Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc Premier Clia Waived 12 panel Tilt Cup, Item No. C12APC
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The co Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5;
Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP;
Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-12BUP;
Immutest 5 panel, Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc iCup Drug Screen Cup, Item No. I-DXA-187-016, I-DXA-167-013;
iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142;
iCup DX 11 Panel w/Adulterant, Item No. I-DXA-1117-131;
iCup DX 12 Panel w/Adultera Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc EDI BZO UNCUT SHEET-CARD, Item No. 100170
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations o Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D;
DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection o Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc DrugSmart 11 Test Cup, Item No. 61127D;
DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D;
DrugSmart 9 Test Cup (BUP), Item No. 60960D;
DrugSmart Cup 10, Item No. 61093D-3C
These Drugs of Abuse Te Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc DrugSmart 10 Test Cup (PCP & MDMA), Item No. 61055D;
DrugSmart 10 Test Cup (PCP & OXY), Item No. 61020D
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple d Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc DrugCheck Waived 12 Panel Cup w/Adult, Item No. DCC-81205-5
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. Th Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc DrugCheck Pipette 10 Drug Test, Item No. 41025 DC
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configur Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc CLIA RDTC 12-Panel Cup and CLIA RDTC 12-Panel Cup (w/Adulteration), Item No. CLIA-RDTC-12
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc ArcPoint Labs 10 Panel Dip Screen (OXY), Item No. APD-10MO
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc 12-Panel Dip Drug Screen with adulterant, Item No. PSDA-12BUP
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc 11 Panel Dip Card (OPI 2000), Item No. 11125AA2K; 11 Panel Dip Card (OPI 300) w/Adult, Item No. 11125AA
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple d Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc 11 Panel Cup (OPI2000) w/Adult, Item No. 71125AA2K
; and 11 Panel Cup (OPI300) w/Adult, Item No. 71125AA
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc 10-Panel Pipette Drug Screen, Item No. PSP-10M
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurati Terminated |
JXM | K052115 K113046 +1 |
| Oct 20, 2015 | Ameditech Inc 1 Step 12 Panel Cup, Item No. NBCA-12M-W
These Drugs of Abuse Tests are one-step immunoassays for the qualitative detection of multiple drugs and drug metabolites in human urine. The configurations of Terminated |
JXM | K052115 K113046 +1 |
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