Visualine II Benzodiazepines
FDA 510(k) K953105 · Sun Biomedical Laboratories, Inc.
510(k) numberK953105
Submission
- Device name
- Visualine II Benzodiazepines
- Applicant
- Sun Biomedical Laboratories, Inc.
Cherry Hill, NJ, US - Received
- July 3, 1995
- Decision date
- October 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|
| K023856 | Visualine Methadone DipstriptestDJR · Traditional | 08/25/2003SE |
| K023648 | Visualine Cup IV for Drugs of Abuse Test for Qualitative Determination of Cocaine…LDJ · Traditional | 05/06/2003SE |
| K014089 | Visualine II (Also Known AS Sunline) BarituratesDIS · Traditional | 04/25/2002SE |
| K020136 | Visualine Barbiturates Dipstrip TestDIS · Traditional | 03/20/2002SE |
| K011499 | Visualine Amphetamine Dipstrip AssayDKZ · Traditional | 07/17/2001SE |
| K010177 | Visualine II (Also Known AS Sunline) Amphetamine AssayDKZ · Traditional | 05/17/2001SE |
| K993485 | Visualine V Drugs of Abuse Dipstrip Panel for Qualitative Determination of Cocaine…DIO · Traditional | 12/27/1999SE |
| K983790 | Visualine II (Also Known AS Sunline) PhencyclidineLCM · Traditional | 03/01/1999SE |
| K981314 | Visualine II (Also Known AS Sunline) MethadoneDJR · Traditional | 09/04/1998SE |
| K972032 | Visualine II MethamphetimineDKZ · Traditional | 08/12/1997SE |
Questions and answers
When was Visualine II Benzodiazepines cleared by the FDA?
Visualine II Benzodiazepines (K953105) received a 510(k) decision of Substantially Equivalent on October 5, 1995, 94 days after the submission was received.
What is the product code of K953105?
The FDA product code is JXM – Enzyme Immunoassay, Benzodiazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3170.