Ameditech Immutest Multi-Drug Screen BUP/PPX/COC150
FDA 510(k) K063015 · Ameditech, Inc.
510(k) numberK063015
Submission
- Device name
- Ameditech Immutest Multi-Drug Screen BUP/PPX/COC150
- Applicant
- Ameditech, Inc.
San Diego, CA, US - Received
- October 2, 2006
- Decision date
- December 20, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual TestDJG · Traditional | Medtox Diagnostics, Inc. | 01/29/2026SE |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | Randox Laboratories Limited | 01/23/2026SE |
| K253082 | LZI Buprenorphine II Enzyme ImmunoassayDJG · Traditional | Lin-Zhi International, Inc. | 01/16/2026SE |
| K252520 | SEFRIA Hydrocodone Oral FluidDJG · Traditional | Immunalysis Corporation | 09/11/2025SE |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative…DJG · Traditional | Healgen Scientific,, LLC | 08/15/2025SE |
| K251634 | LZI Fentanyl III Enzyme ImmunoassayDJG · Special | Lin-Zhi International, Inc. | 06/18/2025SE |
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA ReaderDJG · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 06/14/2024SE |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardDJG · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 05/10/2024SE |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardDJG · Traditional | Co-Innovation Biotech Co., Ltd. | 03/08/2024SE |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine…DJG · Traditional | Shanghai Accurature Diagnostics Co., Ltd. | 02/23/2024SE |
More from Shanghai Accurature Diagnostics Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K113501 | Ameditech Checkcup Multi Drug Test (Flat/Round Cup)DIO · Special | 12/05/2011SE |
| K113046 | Ameditech Immutest Milti-Drug ScreenDKZ · Special | 11/10/2011SE |
| 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 Multi-Drug Screen BUP/PPX/COC150 cleared by the FDA?
Ameditech Immutest Multi-Drug Screen BUP/PPX/COC150 (K063015) received a 510(k) decision of Substantially Equivalent on December 20, 2006, 79 days after the submission was received.
What is the product code of K063015?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.