Aca Urine Benzodiazepines (Ubenz) Screen Method
FDA 510(k) K873538 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK873538
Submission
- Device name
- Aca Urine Benzodiazepines (Ubenz) Screen Method
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Wilmington, DE, US - Received
- September 1, 1987
- Decision date
- October 2, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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| K953725 | Cronex Radiation Therapy Verification CassetteIXA · Traditional | 09/06/1995SE |
| K953724 | Cronex Radiation Therapy CassetteIXA · Traditional | 09/06/1995SE |
| K951441 | Dupont Aca Digoxin (DGN a) MethodKXT · Traditional | 06/01/1995SE |
| K950137 | Urine Barbiturates Screen Flex(Tm) Reagent CartridgeDIS · Traditional | 04/13/1995SE |
| K950181 | Urine Cannabinoids Screen Flex(Tm) Reagent CartridgeLDJ · Traditional | 04/05/1995SE |
| K950136 | Urine Opiates Screen Flex(Tm) Reagent CartridgeDJG · Traditional | 04/05/1995SE |
| K950135 | Urine Amphetamines Screen Flex(Tm) Reagent CartridgeDKZ · Traditional | 03/30/1995SE |
| K950427 | Urine Benzodiazepines Screen Flex Teagent CartridgeJXM · Traditional | 03/21/1995SE |
| K950182 | Urine Methadone Screen Flex(Tm) Reagent CartridgeDIW · Traditional | 03/21/1995SE |
Questions and answers
When was Aca Urine Benzodiazepines (Ubenz) Screen Method cleared by the FDA?
Aca Urine Benzodiazepines (Ubenz) Screen Method (K873538) received a 510(k) decision of Substantially Equivalent on October 2, 1987, 31 days after the submission was received.
What is the product code of K873538?
The FDA product code is JXM – Enzyme Immunoassay, Benzodiazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3170.