510(k) Report

FDA applicant

Ameditech, Inc.

San Diego, CA14 decisions2001–201187 recalls

FDA records 14 decisions for Ameditech, Inc. (San Diego, CA) from 2001 to 2011: 14 510(k) clearances. Most are in product codes DKZ (Enzyme Immunoassay, Amphetamine) and DJG (Enzyme Immunoassay, Opiates). Its devices cite 6 predicates, 6 of them its own earlier devices. 87 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, clinical toxicology panel, where it files most

How often FDA has decided Ameditech, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2011

2011: 2
2007high 2 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

3in 2020

2010: 12011: 22014: 32015: 782020: 3
2007high 78 (2015) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Ameditech, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Ameditech, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • DKZEnzyme Immunoassay, Amphetamine5decisions
  • DJGEnzyme Immunoassay, Opiates2decisions
  • DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites2decisions
  • LAFGas Chromatography, Methamphetamine1decision
  • LCMEnzyme Immunoassay, Phencyclidine1decision
  • DISEnzyme Immunoassay, Barbiturate1decision

Also: LCX (1), LDJ (1).

Who builds on its devices?

Later devices cite its devices 9 times; 6 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K040092Ameditech Immu Test Drug Screen PanelAmeditech, Inc. · 20042cite it
  • K050186Ameditech Immutest Multi-Drug Screen Panel IiiAmeditech, Inc. · 20052cite it
  • K042975Ameditech Immutest Multi-Drug Screen Panel IIAmeditech, Inc. · 20042cite it
  • K053175Ameditech DrugsmartcupAmeditech, Inc. · 20051cites it
  • K113046Ameditech Immutest Milti-Drug ScreenAmeditech, Inc. · 20111cites it
  • K063015Ameditech Immutest Multi-Drug Screen Bup/PPX/COC150Ameditech, Inc. · 20061cites it

What has FDA decided for it lately?

  • K113501Ameditech Checkcup Multi Drug Test (Flat/Round Cup)Ameditech, Inc. · 201179 recalls
  • K113046Ameditech Immutest Milti-Drug ScreenAmeditech, Inc. · 201184 recalls
  • K063015Ameditech Immutest Multi-Drug Screen Bup/PPX/COC150Ameditech, Inc. · 20062 recalls
  • K053175Ameditech DrugsmartcupAmeditech, Inc. · 20052 recalls
  • K050186Ameditech Immutest Multi-Drug Screen Panel IiiAmeditech, Inc. · 20053 recalls
  • K042975Ameditech Immutest Multi-Drug Screen Panel IIAmeditech, Inc. · 20043 recalls
  • K040092Ameditech Immu Test Drug Screen PanelAmeditech, Inc. · 2004
  • K023126Ameditech Immutest HCG Pregancy TestAmeditech, Inc. · 2002

All 14 as Ameditech, Inc. →

What has been recalled?

87 recalls linked to its devices; the latest:

  • K113046ImmuTest Drugs of Abuse Cup (AMT Item Number/ AMT Description): IMCA-5AB-W / "ImmuTest…Aug 18, 2020Class II
  • K113046ProScreen" Drugs of Abuse Test (AMT Item/ AMT Description): PSD-6MB/ "ProScreen" Drugs…Aug 18, 2020Class II
  • K113046Drug Screening Component: Uncut Sheets Part Number/ Description/ LOT Number 100163/ EDI…Aug 18, 2020Class II
  • K0521156 Panel Cup Body and Lid w/Adult (AU), Item No. TDDA-6MBAU-CUPNov 16, 2015Class III
  • K052115DrugSmart 11 Test Cup, Item No. 61127DNov 16, 2015Class III
  • K052115DrugSmart 9 Test Cup (BUP), Item No. 60960DNov 16, 2015Class III