Branan Medical Corporation Monitect Methadone Drug Screen Test, Model 190C and 190D
FDA 510(k) K002417 · Branan Medical Corporation
510(k) numberK002417
Submission
- Device name
- Branan Medical Corporation Monitect Methadone Drug Screen Test, Model 190C and 190D
- Applicant
- Branan Medical Corporation
Irvine, CA, US - Received
- August 8, 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
- DJR – Enzyme Immunoassay, Methadone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3620
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K192433 | LZI Methadone II Enzyme ImmunoassayDJR · Traditional | Lin-Zhi International, Inc. | 10/04/2019SE |
| K182779 | ARK EDDP AssayDJR · Traditional | Ark Diagnostics, Inc. | 11/21/2018SE |
| K170416 | LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300)…DJR · Traditional | Lin-Zhi International, Inc. | 06/26/2017SE |
| K160793 | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of…DJR · Traditional | W.H.P.M., Inc. | 08/17/2016SE |
| K152025 | AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup)…DJR · Traditional | Assure Tech. Co., Ltd. | 10/05/2015SE |
| K151395 | Immunalysis EDDP Specific Urine Enzyme Immunoassay, Immunalysis EDDP Urine Calibrators…DJR · Traditional | Immunalysis Corporation | 07/24/2015SE |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestDJR · Traditional | W.H.P.M., Inc. | 06/29/2015SE |
| K131232 | Wondfo Methadone Urine Test (MTD 200), Wondofo Morphine Urine Test (Mop 100)DJR · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 05/31/2013SE |
| K092272 | Randox Methadone AssayDJR · Traditional | Randox Laboratories, Ltd. | 11/18/2010SE |
| K092258 | Randox Metabolite (Eddp) AssayDJR · Traditional | Randox Laboratories, Ltd. | 11/09/2010SE |
More from Randox Laboratories, Ltd.
| 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 Methadone Drug Screen Test, Model 190C and 190D cleared by the FDA?
Branan Medical Corporation Monitect Methadone Drug Screen Test, Model 190C and 190D (K002417) received a 510(k) decision of Substantially Equivalent on November 22, 2000, 106 days after the submission was received.
What is the product code of K002417?
The FDA product code is DJR – Enzyme Immunoassay, Methadone, a Class II (moderate risk) device regulated under 21 CFR 862.3620.