Ameditech Immutest Drug Screen THC
FDA 510(k) K011813 · Ameditech, Inc.
510(k) numberK011813
Submission
- Device name
- Ameditech Immutest Drug Screen THC
- Applicant
- Ameditech, Inc.
San Diego, CA, US - Received
- June 11, 2001
- Decision date
- October 22, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LDJ – Enzyme Immunoassay, Cannabinoids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
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| K223162 | Healgen® Accurate Oral Fluid Drug Test, Healgen® Accurate Oral Fluid Drug Test COTLDJ · Traditional | Healgen Scientific,, LLC | 03/17/2023SE |
| K192515 | BIOEASY Marijuana Test Dip Card 40, BIOEASY Marijuana Test Dip Card 20, BIOEASY…LDJ · Traditional | Shenzhen Bioeasy Biotechnology Co., Ltd. | 10/11/2019SE |
| K153741 | CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana TestLDJ · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 03/18/2016SE |
| K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test…LDJ · Traditional | Nantong Egens Biotech Co., Ltd. | 11/02/2015SE |
| K151203 | Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators…LDJ · Traditional | Immunalysis Corporation | 06/05/2015SE |
| K141320 | LZI Oral Fluid Cannabinoids Enzyme Immunoassay, LZI Oral Fluid Cannabinoids Calibrators…LDJ · Traditional | Lin-Zhi International, Inc. | 05/28/2015SE |
| K142408 | FaStep Marijuana Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), FaStep…LDJ · Traditional | Polymed Therapeutics, Inc. | 09/25/2014SE |
| K140546 | Healgen THC One Step Marijuana Test , Healgen Mamp One Step Methamphetamine TestLDJ · Traditional | Healgen Scientific,, LLC | 06/06/2014SE |
More from Healgen Scientific,, LLC
| 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 |
| 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 |
Questions and answers
When was Ameditech Immutest Drug Screen THC cleared by the FDA?
Ameditech Immutest Drug Screen THC (K011813) received a 510(k) decision of Substantially Equivalent on October 22, 2001, 133 days after the submission was received.
What is the product code of K011813?
The FDA product code is LDJ – Enzyme Immunoassay, Cannabinoids, a Class II (moderate risk) device regulated under 21 CFR 862.3870.