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) |
|---|---|---|---|
| Jul 13, 2020 | OraSure Technologies, Inc. Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 2 plate Matrix Oral Fluid Coated Micro-Plate. IVD Immunoassay for Benzodiazepines, Product Number: 1110IT Terminated |
JXM | K013882 |
| Jul 13, 2020 | OraSure Technologies, Inc. Orasure Technologies Interept Benzodiazopene Miro-Plate EIA-Benzo EIA 5plate Matrix Oral Fluid Coated Micro-Plate-IVD Immunoassay for Benzodiazepines, Product Number: 1110IB Terminated |
JXM | K013882 |
| Nov 16, 2015 | Ameditech Inc THERMO FISHER 8 DRUG CASSETTE, Item No. MTPA-8MBAU Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc THERMO FISHER 6 DRUG CASSETTE, Item No. MTPA-6MBAU Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc RealityCHECK Tilt Cup 12 Panel + Adult, Item No. RC12TCA Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen Cup CLIA with 6 Panel Drug, Item No. PSCup-6MB-W Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen CLIA Wvd 12 Panel Cup w/Adult., Item No. PSCupA-12M-W Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen CLIA Waived Cup with 8 Drug, Item No. PSCup-8P-W Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen CLIA Waived Cup with 6 Drugs, Item No. PSCup-6BO-W Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen CLIA Waived Cup 6 Drugs w/Adul, Item No. PSCupA-6MB-W Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen 9 Panel Cup w/Adulterants, Item No. PSCUPA-9BO300 Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300 Terminated |
JXM | None listed |
| Nov 16, 2015 | Ameditech Inc ProScreen 8 Panel Dip Card w/Adult, Item No. PSDA-8P, PSDA-8MBO300 Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen 8 Panel Dip Card, Item No. PSD-8P Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen 7 Panel Dip Card, Item No. PSD-7MPB, PSD-7MO, PSD-7M Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen 6 Panel Dip Drug Screen, Item No. PSD-6BUPO3 Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen 6 Panel Dip Card w/Adult (AU), Item No. PSDA-6MBAU Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen 6 Panel Dip Card, Item No. PSCuPSD-6BUP300, PSD-6MTDBO300,
PSD-6BUPO, PSD-6MBO, PSD-6MB, Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen 6 Panel Cup w/Adult (AU), Item No. PSCupA-6MBAU Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen 6 Panel Cassette w/Adult (AU), Item No. PSPA-6MBAU Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen 5 Panel Dip Card w/Adult, Item No. PSDA-5MB300 Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen 5 Panel Dip Card, Item No. PSD-12BUP Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen 12 Panel Dip Card, Item No. PSD-12BUP Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen 12 Panel Cup w/Adult., Item No. PSCupA-12M Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen 10 Panel Dip Card w/Adult, Item No. PSDA-10MO, PSDA-10MMO300,
PSDA-10PPX, PSDA-10BUP, PSD-12BUP, PSD-10M, PSCupA-6MB-W,
PSCup-10MMO300, PSD-5AB, PSD-10CMO3, PSCupA-10MO, PSCupA-12M-W
I-DXA-1 Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen 10 Panel Dip Card, Item No. PSD-10MOX, PSD-10MOB, PSD-10MMO300 Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScProScreen 10 Panel Cup with Adulterants, Item No. PSCupA-10AM Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen 10 Panel Cup, Item No. PSCup-10M Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ProScreen 10 Drug Panel Cassette Test, Item No. PSP-10PPX Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc Micro Screen 6 Panel Cup with Adult (AU), Item No. MSCA-6MBAU Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc Immutest Cup CLIA Waived w/Adulteration, Item No. IMCA-7MT-W Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ImmuTest Cup 7-panel w/ Adulteration, Item No. IMCA-7P Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc ImmuTest 12 Panel Dip Card, Item No. IMD-12MO3 Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc Immutest 12 Panel Cup w/Adulteration, Item No. IMCA-11OP Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc Immutest 5 Pnl Drug Cup w/ Adult -waived, Item No. IMCA-5AB-W Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc Immutest 11 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-11OP Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc Immutest 10 Pnl Drug Screen Cup w/ Adult, Item No. IMCA-10M5 Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc iCup DX 8 Panel w/Adulterant, Item No. I-DXA-187-016 Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc iCup DX 6 Panel w/Adulterant, Item No. I-DXA-167-013 Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc iCup DX 12 Panel w/ Adulterant, Item No. I-DXA-1127-023 Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc iCup DX 11 Panel w/ Adulterant, Item No. I-DXA-1117-131 Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc iCup DX 10 Panel w/Adulterant, Item No. I-DXA-1107-142 Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc EDI BZO Uncut Sheet - Cup*, Item No. 160170 Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc DrugSmart Dip AMP/OPI2/COC/THC/BZO Test, Item No. 30520D Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc DrugSmart Dip (MET/OPI2)+AMP+BZO+COC+THC, Item No. 30600D Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc DrugSmart Cup THC/COC/AMP//MET/OPI2/BZO, Item No. 60600D Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc DrugSmart Cup 10, Item No. 61093D-3C, 61085D, 61015D Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc DrugSmart 9 Test Cup (BUP), Item No. 60960D Terminated |
JXM | K052115 K113046 +1 |
| Nov 16, 2015 | Ameditech Inc DrugSmart 12 Test Cup (Multi & BUP), Item No. 61210D
DrugSmart 12 Test Cup (Multi/Single/BUP), Item No. 61205D Terminated |
JXM | K052115 K113046 +1 |
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