Quickscreen Cocaine 150 Screening Test
FDA 510(k) K103295 · Phamatech, Inc.
510(k) numberK103295
Submission
- Device name
- Quickscreen Cocaine 150 Screening Test
- Applicant
- Phamatech, Inc.
San Diego, CA, US - Received
- November 8, 2010
- Decision date
- February 1, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K181945 | QuickScreen Pro Multi Drug Screening Test, Model 9395ZDKZ · Traditional | 10/18/2018SE |
| K131069 | Quickscreen Amphetine 500 TestDKZ · Traditional | 05/14/2014SE |
| K070098 | Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening…DIS · Traditional | 12/07/2007SE |
| K070009 | At Home Drug Test Models, 9308T and 9308XDIS · Traditional | 12/07/2007SE |
| K043599 | Moments Menopause Check, Model 9113CGJ · Special | 02/25/2005SE |
| K043051 | Quickscreen Oxycodone Test, Models 9120, 9120T, 9120X and 9121DJG · Traditional | 02/07/2005SE |
| K043167 | Phamatech Quickscreen Benzodiazepines Test, Models 9025, 9026, 9027T, 9153T and 9195XJXM · Special | 12/29/2004SE |
| K041578 | Quickscreen, Models 9177X and 9178XLCM · Special | 09/10/2004SE |
| K040575 | Pharmatech Menopause Check, Models 9111 and 9112CGJ · Traditional | 05/20/2004SE |
| K030447 | At Home Drug Cup, Model 9150XMVO · Special | 04/14/2003SE |
Questions and answers
When was Quickscreen Cocaine 150 Screening Test cleared by the FDA?
Quickscreen Cocaine 150 Screening Test (K103295) received a 510(k) decision of Substantially Equivalent on February 1, 2012, 450 days after the submission was received.
What is the product code of K103295?
The FDA product code is DIO – Enzyme Immunoassay, Cocaine And Cocaine Metabolites, a Class II (moderate risk) device regulated under 21 CFR 862.3250.