One Step Urine Drug of Abuse: Benzodiazepine Test
FDA 510(k) K980776 · Tcpi, Inc.
510(k) numberK980776
Submission
- Device name
- One Step Urine Drug of Abuse: Benzodiazepine Test
- Applicant
- Tcpi, Inc.
Simi Valley, CA, US - Received
- March 2, 1998
- Decision date
- April 29, 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 |
|---|---|---|
| K981363 | One Step Urine Drug of Abuse: Phencyclidine (PCP) TestLCM · Traditional | 12/22/1998SE |
| K972960 | Health Check Uri-Test Protein in UrineJIR · Traditional | 10/07/1998SE |
| K981197 | One Step Urine Drug of Abuse Amphetamine TestDKZ · Traditional | 06/16/1998SE |
| K951853 | One Step Urine Drug of Abuse Cannabinoid Test (THC)LDJ · Traditional | 08/20/1996SE |
| K954968 | Health Check Uri-Test Glucose in Urine TestJIL · Traditional | 07/26/1996SE |
| K954685 | Uritest - Nitrite in Urine TestJMT · Traditional | 07/22/1996SE |
| K955353 | One Step Pregnancy HCG Serun Diluent ReagentJHI · Traditional | 03/19/1996SE |
| K952096 | One Step Urine Drug of Abuse Opiate Test (Opium/Heroin/Morphine)DJG · Traditional | 08/17/1995SE |
| K951892 | One Step Urine Drug of Abuse Cocaine TestDIO · Traditional | 08/17/1995SE |
| K941765 | HCG Pregnancy One Step Test Strip for OTC UseLCX · Traditional | 10/20/1994SE |
Questions and answers
When was One Step Urine Drug of Abuse: Benzodiazepine Test cleared by the FDA?
One Step Urine Drug of Abuse: Benzodiazepine Test (K980776) received a 510(k) decision of Substantially Equivalent on April 29, 1998, 58 days after the submission was received.
What is the product code of K980776?
The FDA product code is JXM – Enzyme Immunoassay, Benzodiazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3170.