Branan Medical Corporation Monitect Bzo Drug Screen Test
FDA 510(k) K002342 · Branan Medical Corporation
510(k) numberK002342
Submission
- Device name
- Branan Medical Corporation Monitect Bzo Drug Screen Test
- Applicant
- Branan Medical Corporation
Irvine, CA, US - Received
- August 1, 2000
- Decision date
- November 27, 2000
- 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 |
|---|---|---|
| K122633 | Toxcup Drug Screen CupLDJ · Traditional | 02/07/2013SE |
| K122752 | Fastect II PPX Drug Screen Dipstick, Fastect II Drug Screen Dipstick, Quicktox Drug…JXN · Traditional | 01/30/2013SE |
| K103227 | Oratect Oral Fluid Drug Screen DevicesDIO · Traditional | 04/11/2012SE |
| K082508 | Fastect II Bup Drug Screen Dipstick and Quicktox Bup Drug Screen DipcardDJG · Traditional | 11/21/2008SE |
| K040203 | Monitect Mdma Drug Screen Cassette Test, Model MC22; Fastect II Mdma Drug Screen…DKZ · Traditional | 03/25/2004SE |
| K032057 | Toxcup Drug Screen Cup Amp/Coc/Met/Opi/Pcp/ThcDIO · Special | 08/21/2003SE |
| K030113 | Monitect Oxycodone Drug Screen Cassette Test, Model MC 23, Fastect Oxycodone Drug Screen…DJG · Traditional | 07/02/2003SE |
| K023489 | Quicktox Multiple Drug DipcardDIO · Special | 12/16/2002SE |
| K022355 | Quicktox Multiple Drug Dipcard Coc/Met/Thc/Amp/Pcp/Bzo/Bar/Mtd/Tca, Model QT61DIO · Special | 07/30/2002SE |
| K013124 | Modification to Scooper Drug/Adulteration Test CupDJJ · Special | 11/07/2001SE |
Questions and answers
When was Branan Medical Corporation Monitect Bzo Drug Screen Test cleared by the FDA?
Branan Medical Corporation Monitect Bzo Drug Screen Test (K002342) received a 510(k) decision of Substantially Equivalent on November 27, 2000, 118 days after the submission was received.
What is the product code of K002342?
The FDA product code is JXM – Enzyme Immunoassay, Benzodiazepine, a Class II (moderate risk) device regulated under 21 CFR 862.3170.