Livesure Methadone Screen Tests
FDA 510(k) K013796 · Pan Probe Biotech, Inc.
510(k) numberK013796
Submission
- Device name
- Livesure Methadone Screen Tests
- Applicant
- Pan Probe Biotech, Inc.
San Diego, CA, US - Received
- November 15, 2001
- Decision date
- November 26, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DJR – Enzyme Immunoassay, Methadone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3620
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192433 | LZI Methadone II Enzyme ImmunoassayDJR · Traditional | Lin-Zhi International, Inc. | 10/04/2019SE |
| K182779 | ARK EDDP AssayDJR · Traditional | Ark Diagnostics, Inc. | 11/21/2018SE |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300)…DJR · Traditional | Lin-Zhi International, Inc. | 06/26/2017SE |
| K160793 | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of…DJR · Traditional | W.H.P.M., Inc. | 08/17/2016SE |
| K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…DJR · Traditional | Assure Tech. Co., Ltd. | 10/05/2015SE |
| K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators…DJR · Traditional | Immunalysis Corporation | 07/24/2015SE |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestDJR · Traditional | W.H.P.M., Inc. | 06/29/2015SE |
| K131232 | Wondfo Methadone Urine Test (MTD 200), Wondofo Morphine Urine Test (Mop 100)DJR · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 05/31/2013SE |
| K092272 | Randox Methadone AssayDJR · Traditional | Randox Laboratories, Ltd. | 11/18/2010SE |
| K092258 | Randox Metabolite (Eddp) AssayDJR · Traditional | Randox Laboratories, Ltd. | 11/09/2010SE |
More from Randox Laboratories, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K020968 | Livesure HCG Urinary Pregnancy Test Strip and Test CardJHI · Traditional | 07/15/2002SE |
| K012133 | Livesure Barbiturates Screen TestDIS · Traditional | 07/20/2001SE |
| K012131 | Livesure Benzodiazepines Screen TestsJXM · Traditional | 07/20/2001SE |
| K012107 | Livesure Phenecycline (PCP) Screen TestsLCM · Traditional | 07/20/2001SE |
| K011610 | Livesure Methamphetamine Screen TestsLAF · Traditional | 06/08/2001SE |
| K011609 | Livesure Amphetamine Screen TestDKZ · Traditional | 06/08/2001SE |
| K010967 | Livesure Cocaine Screen TestDIO · Traditional | 04/17/2001SE |
| K011011 | Livesure Morphine Screen TestDOE · Traditional | 04/13/2001SE |
| K010001 | Livesure THC Screen TestLDJ · Traditional | 02/05/2001SE |
Questions and answers
When was Livesure Methadone Screen Tests cleared by the FDA?
Livesure Methadone Screen Tests (K013796) received a 510(k) decision of Substantially Equivalent on November 26, 2001, 11 days after the submission was received.
What is the product code of K013796?
The FDA product code is DJR – Enzyme Immunoassay, Methadone, a Class II (moderate risk) device regulated under 21 CFR 862.3620.