Quikstrip One Step Benzodiazepine Test
FDA 510(k) K973269 · Drial Consultants, Inc.
510(k) numberK973269
Submission
- Device name
- Quikstrip One Step Benzodiazepine Test
- Applicant
- Drial Consultants, Inc.
Simi Valley, CA, US - Received
- August 29, 1997
- Decision date
- February 25, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K973326 | Quikpac II One Step Benzodiazepine TestJXM · Traditional | 02/24/1998SE |
| K973047 | One Step Urine Drug of Abuse Barbiturate TestDIS · Traditional | 10/02/1997SE |
| K972059 | Quikpac II One Step Cocaine TestDIO · Traditional | 08/28/1997SE |
| K972571 | Quikstrip One Step Opiates TestDJG · Traditional | 08/20/1997SE |
| K972405 | Quikpac II One Step Opiate TestDJG · Traditional | 08/08/1997SE |
| K971926 | Quikstrip One Step Cocaine TestDIO · Traditional | 07/14/1997SE |
| K970395 | Quikstrip One Step MethamphetamineDKZ · Traditional | 06/26/1997SE |
| K971218 | Quikstrip One Step Amphetamine TestDKZ · Traditional | 05/30/1997SE |
| K971109 | Quikpac II One Step Amphetamine TestDKZ · Traditional | 05/14/1997SE |
| K970724 | Quickpac II One Step Methamphetamine TestDKZ · Traditional | 05/13/1997SE |
Questions and answers
When was Quikstrip One Step Benzodiazepine Test cleared by the FDA?
Quikstrip One Step Benzodiazepine Test (K973269) received a 510(k) decision of Substantially Equivalent on February 25, 1998, 180 days after the submission was received.
What is the product code of K973269?
The FDA product code is JXM – Enzyme Immunoassay, Benzodiazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3170.