Company ยท US
Ameditech Inc
FDA 510(k) clearances and medical device recalls filed under this name, 2001 to 2011. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
111recalls (0 in 12 months)
105recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JXM | Enzyme Immunoassay, Benzodiazepine | 79 |
| DKZ | Enzyme Immunoassay, Amphetamine | 13 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 10 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 8 |
| DKC | Alcohol Control Materials | 5 |
| DJG | Enzyme Immunoassay, Opiates | 3 |
| LFH | U.V. Spectrometry, Tricyclic Antidepressant Drugs | 2 |
| DIS | Enzyme Immunoassay, Barbiturate | 1 |
| LAF | Gas Chromatography, Methamphetamine | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 |
| NGG | Test, Methamphetamine, Over The Counter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 5, 2011 | K113501 | AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) Ameditech, Inc. | DIO |
| Nov 10, 2011 | K113046 | AMEDITECH IMMUTEST MILTI-DRUG SCREEN Ameditech, Inc. | DKZ |
| Dec 20, 2006 | K063015 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 Ameditech, Inc. | DJG |
| Dec 8, 2005 | K053175 | AMEDITECH DRUGSMARTCUP Ameditech, Inc. | DKZ |
| Mar 4, 2005 | K050186 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III Ameditech, Inc. | DKZ |
| Dec 29, 2004 | K042975 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II Ameditech, Inc. | DIS |
| Mar 8, 2004 | K040092 | AMEDITECH IMMU TEST DRUG SCREEN PANEL Ameditech, Inc. | DKZ |
| Nov 18, 2002 | K023126 | AMEDITECH IMMUTEST HCG PREGANCY TEST Ameditech, Inc. | LCX |
| Nov 30, 2001 | K012582 | AMEDITECH IMMUTEST DRUG SCREEN PCP Ameditech, Inc. | LCM |
| Nov 30, 2001 | K012484 | AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE Ameditech, Inc. | DKZ |
| Nov 30, 2001 | K012483 | AMEDITECH IMMUTEST DRUG SCREEN OPIATES Ameditech, Inc. | DJG |
| Nov 16, 2001 | K012585 | AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE Ameditech, Inc. | LAF |
| Oct 22, 2001 | K011814 | AMEDITECH IMMUTEST DRUG SCREEN COC Ameditech, Inc. | DIO |
| Oct 22, 2001 | K011813 | AMEDITECH IMMUTEST DRUG SCREEN THC Ameditech, Inc. | LDJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 18, 2020 | Ameditech Inc Drug Screening Component: Uncut Sheets
Part Number/ Description/ LOT Number
100163/ EDI OPI (300) Uncut Sheet-Card /187876,
100195/ EDI PPX Uncut Sheet-Card/ 187877,
160130/ EDI COC Uncut Sheet-Cup/ 1 Terminated |
DIO | K113046 K113501 |
| 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 |
| Aug 18, 2020 | Ameditech Inc First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B Terminated |
LDJ | K122633 |
| Aug 18, 2020 | Ameditech Inc First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B Terminated |
DKC | K052115 |
| Aug 18, 2020 | Ameditech Inc ToxCup Drug Screen Cup (AMT Item Number/ AMT Description):
HT29A/"ToxCup Drug Screen Cup
COC300/MET500/OPI300/THC50/AMP1000/PCP25/OXY100
Adulteration Screen for CR - NI - PH - BL - S.G.",
DT14/ "T Terminated |
DIO | K032057 K122633 |
| Aug 18, 2020 | Ameditech Inc TDDA Drugs of Abuse Cup(AMT Item/ AMT Description):
TDDA-6MBAU-CUP /"TDDA Drugs of Abuse Cup
AMP300/BZO200/COC300/MET300/OPI300/ THC50 with Cr, Ni, pH, Bl, S.G." Terminated |
DIO | None listed |
| Aug 18, 2020 | Ameditech Inc QuickTox Drug Screen DipCard(AMT Item/ AMT Description):
QT70/ "QuickTox Drug Screen Dipcard 11 Drug Detection: COC300+OPI300+MET500+THC50+AMP1000+PCP25+BZO300+BAR300+MTD300+OXY100+MDMA500",
QT88/ " Terminated |
DIO | None listed |
| Aug 18, 2020 | Ameditech Inc ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description):
PSD-6MB/ "ProScreen" Drugs of Abuse Test
(MET1000/OPI2000)+AMP+BZO+COC+THC",
PSD-6MTDBO-300 /"ProScreen" Drugs of Abuse Test
(COC/THC)+BZO Terminated |
DKC | K052115 K113046 |
| Aug 18, 2020 | Ameditech Inc Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description):
HM12-CE "Oratect III Oral Fluid Drug Screen Device
MET25+THC40+COC20+AMP25+OPI10+BZO5 " Terminated |
LDJ | None listed |
| Aug 18, 2020 | Ameditech Inc iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description):
X11-I-DXA-2147-011/ "iCup" Dx 14 Drug Screen Cup
14 Drug Detection: (THC50/COC150)+(MOP300/MET500)+(AMP500/BZO300)+
(BAR300/MTD300)+(BUPG1 Terminated |
LDJ | K122633 |
| Aug 18, 2020 | Ameditech Inc Noble 1 Step+ Cup (AMT Item Number/ AMT Description):
NBCA-13A-B /"Noble 1 Step + Cup"
THC50/COC150; OPI300/MET500; AMP500/BZO300;
BAR300/MTD300; BUPG10/TCA1000; MDMA500/OXY100;
w/ Cr, Ni, pH, Bl, Terminated |
LDJ | K122633 |
| Aug 18, 2020 | Ameditech Inc MicroTox (AMT Item Number/ AMT Description):
MTPA-6MBAU / "MicroTox
(AMP300/BZO200)+(COC300/THC50)+ (MET300/MOR300)
With Cr, Ni, pH, Bl, S.G.",
MTPA-6MBAU/ "MicroTox
(AMP300/BZO200)+(COC300/THC50) Terminated |
DKC | None listed |
| Aug 18, 2020 | Ameditech Inc MicroScreen (AMT Item Number/ AMT Description):
MSCA-6MBAU/ "MicroScreen
AMP300/BZO200/COC300/MET300/OPI300/ THC50
with Cr, Ni, pH, Bl, S.G. " Terminated |
DKC | None listed |
| Aug 18, 2020 | Ameditech Inc ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description):
IMCA-5AB-W / "ImmuTest Drugs of Abuse Cup
AMP1000+BZO300+COC300+OPI2000+THC50
With Cr, Ni, pH, Bl, S.G.",
IMC-8BBCE/ "ImmuTest Drugs Terminated |
DKC | K052115 K113046 |
| Aug 18, 2020 | Ameditech Inc Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description):
570-1066 / "Henry Schein OneStep+ DOA Cup 14 Panel
AMP500/BAR/BUPG/BZO/COC150/MDMA/MET500/MOP/MTD/OXY/PCP/PPX/TCA/THC (Bl, Cr, Ni, Terminated |
LDJ | K122633 |
| Aug 18, 2020 | Ameditech Inc Fastect II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT Description):
MF25/ "Fastect II Drug Screen Dipstick Test Single Drug Detection: BUP10", QF09/"Fastect II Drug Screen Terminated |
DIO | K022355 K030113 |
| Aug 18, 2020 | Ameditech Inc Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description):
164-DXA14 /"Consult Diagnostics
DRUGS OF ABUSE TEST CUP 14-DRUG PANEL WITH ADULTERANTS
AMP500/BAR/BUPG/BZO/COC150/MDMA/MET Terminated |
LDJ | K122633 |
| Aug 18, 2020 | Ameditech Inc CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description):
X07-CLIA-SDDT-25 / CLIA Waived" Inc. Single Drug Dipstick Test
BUP10,
X07-CLIA-SDDT-25 / "CLIA Waived" Inc. Single Drug Dipstick Test Terminated |
LDJ | K122633 |
| Aug 18, 2020 | Ameditech Inc Alere iCup Drug Detection (AMT Item Number/ AMT Description):
I-DXA-10/ "Alere" iCup Dx 10 Drug Detection + Adulteration AMP/BAR/BZO/COC/MET/MDMA/MTD/MOP/OXY/THC
Bl, Cr, Ni, pH, SG",
I-DXA-13B/"Aler Terminated |
DIO | K052115 K122633 |
| Aug 18, 2020 | Ameditech Inc Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description):
X11-IS12-DX / "Alere iScreen" Dx Multi-Drugs of Abuse Dip Test
12 Drug Detection:AMP1000+BAR300+BZO300+COC300+THC50+MTD300+MET5 Terminated |
DIO | K082508 |
| Aug 18, 2020 | Ameditech Inc Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description):
X11-IS1 BUP-DX/ "Alere iScreen" Dx Single Dip Card Single Drug Detection: Buprenorphine (BUP)",
X11-IS1 BAR-DX /"Alere iScreen" Terminated |
DIO | K022335 K082508 |
| Dec 17, 2019 | Ameditech Inc QuickTox 5 Panel Drug Screen DipCard Terminated |
DJG | K022355 |
| Dec 15, 2017 | Ameditech Inc Alere iScreen Dx Urine Drug Screen Card Terminated |
LFH | K022355 |
| Sep 30, 2017 | Ameditech Inc Accutest Drug Test Cup 5+3
Product Usage:
The Accutest Drug Test Cup is an in vitro diagnostic test for the rapid detection of multiple drugs in human urine. The test is intended as the first step in Terminated |
NGG | K082898 |
| Jun 26, 2017 | Ameditech Inc Alere iScreen Dx Urine Drug Screen Card, 20 Drug Detection, Kit Contents include 26 individually pouched devices and 1 IFU insert.
The Alere iScreen Dx Drug Screen Card is a rapid urine screening te Terminated |
LFH | K022355 |
| 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 |
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