Livesure Benzodiazepines Screen Tests
FDA 510(k) K012131 · Pan Probe Biotech, Inc.
510(k) numberK012131
Submission
- Device name
- Livesure Benzodiazepines Screen Tests
- Applicant
- Pan Probe Biotech, Inc.
San Diego, CA, US - Received
- July 9, 2001
- Decision date
- July 20, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- JXM – Enzyme Immunoassay, Benzodiazepine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3170
- Specialty
- Clinical Toxicology
Other 510(k)s with product code JXM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243498 | Alinity c Benzodiazepines Reagent KitJXM · Special | Microgenics Corporation | 12/11/2024SE |
| K221765 | ONLINE DAT Benzodiazepines IIJXM · Traditional | Roche Diagnostics | 12/23/2022SE |
| K190968 | CEDIA Benzodiazepine AssayJXM · Traditional | Microgenics Corporation | 12/09/2019SE |
| K173963 | DRI Benzodiazepine AssayJXM · Traditional | Microgenics Corporation | 02/21/2018SE |
| K163590 | Psychemedics Microplate EIA for Benzodiazepines in HairJXM · Traditional | Psychemedics Corporation | 09/15/2017SE |
| K163704 | Healgen Multi-Drug Urine Test Cup; Healgen Multi-Drug Urine Test Dip CardJXM · Special | Healgen Scientific,, LLC | 08/02/2017SE |
| K153597 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM · Special | Healgen Scientific,, LLC | 05/23/2016SE |
| K151771 | Immunalysis Benzodiazepines Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsJXM · Traditional | Immunalysis Corporation | 01/05/2016SE |
| K151642 | Heagen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM · Special | Healgen Scientific,, LLC | 08/13/2015SE |
| K150356 | Healgen Multi-Drug Urine Test Cup, Healgen Multi-Drug Urine Test Dip CardJXM · Special | Healgen Scientific,, LLC | 05/13/2015SE |
More from Healgen Scientific,, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K020968 | Livesure HCG Urinary Pregnancy Test Strip and Test CardJHI · Traditional | 07/15/2002SE |
| K013796 | Livesure Methadone Screen TestsDJR · Traditional | 11/26/2001SE |
| K012133 | Livesure Barbiturates Screen TestDIS · 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 Benzodiazepines Screen Tests cleared by the FDA?
Livesure Benzodiazepines Screen Tests (K012131) received a 510(k) decision of Substantially Equivalent on July 20, 2001, 11 days after the submission was received.
What is the product code of K012131?
The FDA product code is JXM – Enzyme Immunoassay, Benzodiazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3170.