Ameditech Immutest Multi-Drug Screen Panel II
FDA 510(k) K042975 · Ameditech, Inc.
510(k) numberK042975
Submission
- Device name
- Ameditech Immutest Multi-Drug Screen Panel II
- Applicant
- Ameditech, Inc.
San Diego, CA, US - Received
- October 28, 2004
- Decision date
- December 29, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DIS – Enzyme Immunoassay, Barbiturate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3150
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DIS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsDIS · Traditional | Immunalysis Corporation | 10/14/2016SE |
| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech…DIS · Traditional | Assure Tech. Co., Ltd. | 06/04/2015SE |
| K150791 | Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test…DIS · Traditional | Healgen Scientific,, LLC | 04/24/2015SE |
| K143535 | CR3 Keyless Split Sample Cup Secobarbital- MethadoneDIS · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 01/13/2015SE |
| K140665 | GenPrime Snap-Top Split Key CupDIS · Traditional | Genprime, Inc. | 12/08/2014SE |
| K140215 | One Step Single/Multi-Drug Test Cup/DipcardDIS · Traditional | Co-Innovation Biotech Co., Ltd. | 06/16/2014SE |
| K092268 | Randox Bariturates AssayDIS · Traditional | Randox Laboratories, Ltd. | 05/25/2011SE |
| K110515 | Ucp Drug Screening Test CupsDIS · Special | Ucp Biosciences, Inc. | 04/20/2011SE |
| K070098 | Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening…DIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
| K070009 | At Home Drug Test Models, 9308T and 9308XDIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
More from Phamatech, Inc.
| 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 |
| 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 |
| 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 Panel II cleared by the FDA?
Ameditech Immutest Multi-Drug Screen Panel II (K042975) received a 510(k) decision of Substantially Equivalent on December 29, 2004, 62 days after the submission was received.
What is the product code of K042975?
The FDA product code is DIS – Enzyme Immunoassay, Barbiturate, a Class II (moderate risk) device regulated under 21 CFR 862.3150.