Fastect II Bup Drug Screen Dipstick and Quicktox Bup Drug Screen Dipcard
FDA 510(k) K082508 · Branan Medical Corporation
510(k) numberK082508
Submission
- Device name
- Fastect II Bup Drug Screen Dipstick and Quicktox Bup Drug Screen Dipcard
- Applicant
- Branan Medical Corporation
Irvine, CA, US - Received
- August 29, 2008
- Decision date
- November 21, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DJG – Enzyme Immunoassay, Opiates
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3650
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DJG
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|---|---|---|---|
| K252684 | Labcorp Fentanyl Urine Visual TestDJG · Traditional | Medtox Diagnostics, Inc. | 01/29/2026SE |
| K250741 | Evidence MultiSTAT DOA Urine MultiPlexDJG · Traditional | Randox Laboratories Limited | 01/23/2026SE |
| K253082 | LZI Buprenorphine II Enzyme ImmunoassayDJG · Traditional | Lin-Zhi International, Inc. | 01/16/2026SE |
| K252520 | SEFRIA Hydrocodone Oral FluidDJG · Traditional | Immunalysis Corporation | 09/11/2025SE |
| K251972 | Healgen® AccuFluor Fentanyl Fluorescence Immunoassay (FIA)Test Kit - Qualitative…DJG · Traditional | Healgen Scientific,, LLC | 08/15/2025SE |
| K251634 | LZI Fentanyl III Enzyme ImmunoassayDJG · Special | Lin-Zhi International, Inc. | 06/18/2025SE |
| K240124 | BioSieve Fentanyl FIA Test Kit; BioSieve ToxiSmart FIA ReaderDJG · Traditional | Vivachek Biotech (Hangzhou) Co., Ltd. | 06/14/2024SE |
| K240698 | Dochek® Multi-Drug Urine Test Dipcard Rx; Dochek® Multi-Drug Urine Test DipcardDJG · Traditional | Guangzhou Decheng Biotechnology Co., Ltd. | 05/10/2024SE |
| K231904 | Rapid Fentanyl (FYL) Test Strip, Rapid Fentanyl (FYL) Test DipcardDJG · Traditional | Co-Innovation Biotech Co., Ltd. | 03/08/2024SE |
| K232228 | Multi-drug Urine Test Cup, Multi-drug Urine Test Dip Card, Accurature Multi-drug Urine…DJG · Traditional | Shanghai Accurature Diagnostics Co., Ltd. | 02/23/2024SE |
More from Shanghai Accurature Diagnostics Co., 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 |
| 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 |
| K012541 | Modification To:Fastix Thc/Coc Drug Screen Dipstick Test, Fastix Thc/Coc/Met Drug Screen…LDJ · Special | 09/04/2001SE |
Questions and answers
When was Fastect II Bup Drug Screen Dipstick and Quicktox Bup Drug Screen Dipcard cleared by the FDA?
Fastect II Bup Drug Screen Dipstick and Quicktox Bup Drug Screen Dipcard (K082508) received a 510(k) decision of Substantially Equivalent on November 21, 2008, 84 days after the submission was received.
What is the product code of K082508?
The FDA product code is DJG – Enzyme Immunoassay, Opiates, a Class II (moderate risk) device regulated under 21 CFR 862.3650.