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Ameditech Inc

FDA Regulatory Profile

Summary

Total Recalls
109
510(k) Clearances
14
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-3034-2020Class IIFastect¿ II Drug Screen Dipstick Test Single Drug Detection (AMT Item Number/ AMT Description): MAugust 18, 2020
Z-3045-2020Class IIToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup¿ Drug Screen Cup COC3August 18, 2020
Z-3048-2020Class IIFirst Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600BAugust 18, 2020
Z-3044-2020Class IITDDA Drugs of Abuse Cup(AMT Item/ AMT Description): TDDA-6MBAU-CUP /"TDDA Drugs of Abuse Cup AMPAugust 18, 2020
Z-3030-2020Class IIAlere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-IS12-DX / "Alere iScreeAugust 18, 2020
Z-3035-2020Class IIHenry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneSAugust 18, 2020
Z-3043-2020Class IIQuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ Drug Screen Dipcard 11 August 18, 2020
Z-3040-2020Class IIiCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 DruAugust 18, 2020
Z-3042-2020Class IIProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse TAugust 18, 2020
Z-3051-2020Class IIDrug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) August 18, 2020
Z-3037-2020Class IIMicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AMP300/BZO200/COC300/MET3August 18, 2020
Z-3032-2020Class IICLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-SDDT-25 / CLIA Waived" August 18, 2020
Z-3038-2020Class IIMicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP300/BZO200)+(COC300/THC5August 18, 2020
Z-3031-2020Class IIAlere iCup Drug Detection (AMT Item Number/ AMT Description): I-DXA-10/ "Alere" iCup¿ Dx 10 Drug August 18, 2020
Z-3036-2020Class IIImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of AAugust 18, 2020
Z-3041-2020Class IIOratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect¿ IAugust 18, 2020
Z-3047-2020Class IIFirst Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700BAugust 18, 2020
Z-3029-2020Class IIAlere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iScAugust 18, 2020
Z-3049-2020Class IIFirst Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100BAugust 18, 2020
Z-3046-2020Class IIFirst Check 1 Panel Drug Cup: (THC); AMT Item Number 990400BAugust 18, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K113501AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)December 5, 2011
K113046AMEDITECH IMMUTEST MILTI-DRUG SCREENNovember 10, 2011
K063015AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150December 20, 2006
K053175AMEDITECH DRUGSMARTCUPDecember 8, 2005
K050186AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL IIIMarch 4, 2005
K042975AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL IIDecember 29, 2004
K040092AMEDITECH IMMU TEST DRUG SCREEN PANELMarch 8, 2004
K023126AMEDITECH IMMUTEST HCG PREGANCY TESTNovember 18, 2002
K012582AMEDITECH IMMUTEST DRUG SCREEN PCPNovember 30, 2001
K012484AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINENovember 30, 2001
K012483AMEDITECH IMMUTEST DRUG SCREEN OPIATESNovember 30, 2001
K012585AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINENovember 16, 2001
K011814AMEDITECH IMMUTEST DRUG SCREEN COCOctober 22, 2001
K011813AMEDITECH IMMUTEST DRUG SCREEN THCOctober 22, 2001