Branan Medical Corporation Monitect Barbiturates Drug Screen Test
FDA 510(k) K002337 · Branan Medical Corporation
510(k) numberK002337
Submission
- Device name
- Branan Medical Corporation Monitect Barbiturates Drug Screen Test
- Applicant
- Branan Medical Corporation
Irvine, CA, US - Received
- August 1, 2000
- Decision date
- November 22, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DIS – Enzyme Immunoassay, Barbiturate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3150
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DIS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K161714 | Immunalysis Barbiturates Urine Enzyme Immunoassay, Immunalysis Multi-Drug CalibratorsDIS · Traditional | Immunalysis Corporation | 10/14/2016SE |
| K151211 | AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech…DIS · Traditional | Assure Tech. Co., Ltd. | 06/04/2015SE |
| K150791 | Healgen Secobarbital Test(Strip, Cassette, Cup, Dip Card), Healgen Burprenorphine Test…DIS · Traditional | Healgen Scientific,, LLC | 04/24/2015SE |
| K143535 | CR3 Keyless Split Sample Cup Secobarbital- MethadoneDIS · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 01/13/2015SE |
| K140665 | GenPrime Snap-Top Split Key CupDIS · Traditional | Genprime, Inc. | 12/08/2014SE |
| K140215 | One Step Single/Multi-Drug Test Cup/DipcardDIS · Traditional | Co-Innovation Biotech Co., Ltd. | 06/16/2014SE |
| K092268 | Randox Bariturates AssayDIS · Traditional | Randox Laboratories, Ltd. | 05/25/2011SE |
| K110515 | Ucp Drug Screening Test CupsDIS · Special | Ucp Biosciences, Inc. | 04/20/2011SE |
| K070098 | Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening…DIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
| K070009 | At Home Drug Test Models, 9308T and 9308XDIS · Traditional | Phamatech, Inc. | 12/07/2007SE |
More from Phamatech, Inc.
| 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 Barbiturates Drug Screen Test cleared by the FDA?
Branan Medical Corporation Monitect Barbiturates Drug Screen Test (K002337) received a 510(k) decision of Substantially Equivalent on November 22, 2000, 113 days after the submission was received.
What is the product code of K002337?
The FDA product code is DIS – Enzyme Immunoassay, Barbiturate, a Class II (moderate risk) device regulated under 21 CFR 862.3150.