Toxcup Drug Screen Cup Amp/Coc/Met/Opi/Pcp/Thc
FDA 510(k) K032057 · Branan Medical Corp.
510(k) numberK032057
Submission
- Device name
- Toxcup Drug Screen Cup Amp/Coc/Met/Opi/Pcp/Thc
- Applicant
- Branan Medical Corp.
Irvine, CA, US - Received
- July 2, 2003
- Decision date
- August 21, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DIO – Enzyme Immunoassay, Cocaine And Cocaine Metabolites
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3250
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DIO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213211 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM)…DIO · Traditional | Carolina Liquid Chemistries Corp. | 01/27/2022SE |
| K211973 | DRI Cocaine Metabolite AssayDIO · Traditional | Microgenics Corporation | 09/24/2021SE |
| K191638 | Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayDIO · Traditional | Medtest DX | 03/12/2020SE |
| K181499 | DRI Cocaine Metabolite AssayDIO · Traditional | Microgenics Corporation | 07/06/2018SE |
| K170293 | Emit II Plus Cocaine Metabolite AssayDIO · Traditional | Siemens Healthcare Diagnostics, Inc. | 10/25/2017SE |
| K163570 | Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)DIO · Traditional | Carolina Liquid Chemistries Corporation | 08/15/2017SE |
| K162395 | MP DOA-10 Panel Test Cup, MP DOA-11 Panel Test CupDIO · Special | Mp Biomedicals, LLC | 06/02/2017SE |
| K152232 | Quest Diagnostics HairCheck-DT (Cocaine)DIO · Traditional | Quest Diagnostics Incorporated | 11/18/2016SE |
| K161214 | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC…DIO · Traditional | Guangzhou Wondfo Biotech Co., Ltd. | 06/27/2016SE |
| K153646 | SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test…DIO · Traditional | Safecare Biotech (Hangzhou) Co., Ltd. | 03/18/2016SE |
More from Safecare Biotech (Hangzhou) 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 |
| 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 |
| 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 Toxcup Drug Screen Cup Amp/Coc/Met/Opi/Pcp/Thc cleared by the FDA?
Toxcup Drug Screen Cup Amp/Coc/Met/Opi/Pcp/Thc (K032057) received a 510(k) decision of Substantially Equivalent on August 21, 2003, 50 days after the submission was received.
What is the product code of K032057?
The FDA product code is DIO – Enzyme Immunoassay, Cocaine And Cocaine Metabolites, a Class II (moderate risk) device regulated under 21 CFR 862.3250.