Ameditech Inc
FDA Regulatory Profile
Ameditech Inc appears in FDA public data with 109 recalls, 14 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3045-2020, Class II) was initiated on August 18, 2020. Its most recent 510(k) clearance was granted on December 5, 2011.
Summary
- Total Recalls
- 109
- 510(k) Clearances
- 14
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3045-2020 | Class II | ToxCup Drug Screen Cup (AMT Item Number/ AMT Description): HT29A/"ToxCup¿ Drug Screen Cup COC3 | August 18, 2020 |
| Z-3041-2020 | Class II | Oratect III Oral Fluid Drug Screen Device (AMT Item Number/ AMT Description): HM12-CE "Oratect¿ I | August 18, 2020 |
| Z-3030-2020 | Class II | Alere iScreen Multi Drug Detection (AMT Item Number/ AMT Description): X11-IS12-DX / "Alere iScree | August 18, 2020 |
| Z-3029-2020 | Class II | Alere iScreen Single Drug Detection (AMT Item Number/ AMT Description): X11-IS1 BUP-DX/ "Alere iSc | August 18, 2020 |
| Z-3050-2020 | Class II | First Check 7 Panel Drug Cup: (AMP/COC/MDMA/MET/OPI/PCP/THC); AMT Item Number 990100B | August 18, 2020 |
| Z-3038-2020 | Class II | MicroTox (AMT Item Number/ AMT Description): MTPA-6MBAU / "MicroTox (AMP300/BZO200)+(COC300/THC5 | August 18, 2020 |
| Z-3037-2020 | Class II | MicroScreen (AMT Item Number/ AMT Description): MSCA-6MBAU/ "MicroScreen AMP300/BZO200/COC300/MET3 | August 18, 2020 |
| Z-3035-2020 | Class II | Henry Schein One Step + DOA Cup (AMT Item Number/ AMT Description): 570-1066 / "Henry Schein OneS | August 18, 2020 |
| Z-3032-2020 | Class II | CLIA Waived Rapid Drug Test (AMT Item Number/ AMT Description): X07-CLIA-SDDT-25 / CLIA Waived" | August 18, 2020 |
| Z-3051-2020 | Class II | Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI OPI (300) | August 18, 2020 |
| Z-3039-2020 | Class II | Noble 1 Step+ Cup (AMT Item Number/ AMT Description): NBCA-13A-B /"Noble 1 Step + Cup" THC50/COC | August 18, 2020 |
| Z-3046-2020 | Class II | First Check 1 Panel Drug Cup: (THC); AMT Item Number 990400B | August 18, 2020 |
| Z-3040-2020 | Class II | iCup Dx14 Drug Screen Cup(AMT Item Number/ AMT Description): X11-I-DXA-2147-011/ "iCup" Dx 14 Dru | August 18, 2020 |
| Z-3048-2020 | Class II | First Check 2 Panel Drug Cup: (THC/COC); AMT Item Number 990600B | August 18, 2020 |
| Z-3036-2020 | Class II | ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest Drugs of A | August 18, 2020 |
| Z-3042-2020 | Class II | ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs of Abuse T | August 18, 2020 |
| Z-3033-2020 | Class II | Consult Diagnostics Drugs Abuse Test Cup (AMT Item Number/ AMT Description): 164-DXA14 /"Consult | August 18, 2020 |
| Z-3047-2020 | Class II | First Check 14 Panel Drug Cup: (BMC style); AMT Item Number 990700B | August 18, 2020 |
| Z-3049-2020 | Class II | First Check 4 Panel Drug Cup: COC/MET1000/OPI2000/THC): (THC/COC); AMT Item Number 990100B | August 18, 2020 |
| Z-3043-2020 | Class II | QuickTox Drug Screen DipCard(AMT Item/ AMT Description): QT70/ "QuickTox¿ Drug Screen Dipcard 11 | August 18, 2020 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K113501 | AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP) | December 5, 2011 |
| K113046 | AMEDITECH IMMUTEST MILTI-DRUG SCREEN | November 10, 2011 |
| K063015 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN BUP/PPX/COC150 | December 20, 2006 |
| K053175 | AMEDITECH DRUGSMARTCUP | December 8, 2005 |
| K050186 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III | March 4, 2005 |
| K042975 | AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II | December 29, 2004 |
| K040092 | AMEDITECH IMMU TEST DRUG SCREEN PANEL | March 8, 2004 |
| K023126 | AMEDITECH IMMUTEST HCG PREGANCY TEST | November 18, 2002 |
| K012582 | AMEDITECH IMMUTEST DRUG SCREEN PCP | November 30, 2001 |
| K012483 | AMEDITECH IMMUTEST DRUG SCREEN OPIATES | November 30, 2001 |
| K012484 | AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE | November 30, 2001 |
| K012585 | AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE | November 16, 2001 |
| K011814 | AMEDITECH IMMUTEST DRUG SCREEN COC | October 22, 2001 |
| K011813 | AMEDITECH IMMUTEST DRUG SCREEN THC | October 22, 2001 |