Ameditech Immutest Milti-Drug Screen
FDA 510(k) K113046 · Ameditech, Inc.
510(k) numberK113046
Submission
- Device name
- Ameditech Immutest Milti-Drug Screen
- Applicant
- Ameditech, Inc.
San Diego, CA, US - Received
- October 13, 2011
- Decision date
- November 10, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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More from Alfa Scientific Designs, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K113501 | Ameditech Checkcup Multi Drug Test (Flat/Round Cup)DIO · Special | 12/05/2011SE |
| K063015 | Ameditech Immutest Multi-Drug Screen BUP/PPX/COC150DJG · Traditional | 12/20/2006SE |
| K053175 | Ameditech DrugsmartcupDKZ · Special | 12/08/2005SE |
| K050186 | Ameditech Immutest Multi-Drug Screen Panel IIIDKZ · Traditional | 03/04/2005SE |
| K042975 | Ameditech Immutest Multi-Drug Screen Panel IIDIS · Traditional | 12/29/2004SE |
| K040092 | Ameditech Immu Test Drug Screen PanelDKZ · Special | 03/08/2004SE |
| K023126 | Ameditech Immutest HCG Pregancy TestLCX · Traditional | 11/18/2002SE |
| K012582 | Ameditech Immutest Drug Screen PCPLCM · Traditional | 11/30/2001SE |
| K012484 | Ameditech Immutest Drug Screen AmphetamineDKZ · Traditional | 11/30/2001SE |
| K012483 | Ameditech Immutest Drug Screen OpiatesDJG · Traditional | 11/30/2001SE |
Questions and answers
When was Ameditech Immutest Milti-Drug Screen cleared by the FDA?
Ameditech Immutest Milti-Drug Screen (K113046) received a 510(k) decision of Substantially Equivalent on November 10, 2011, 28 days after the submission was received.
What is the product code of K113046?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.