QuickScreen Pro Multi Drug Screening Test, Model 9395Z
FDA 510(k) K181945 · Phamatech, Inc.
510(k) numberK181945
Submission
- Device name
- QuickScreen Pro Multi Drug Screening Test, Model 9395Z
- Applicant
- Phamatech, Inc.
San Diego, CA, US - Received
- July 20, 2018
- Decision date
- October 18, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DKZ – Enzyme Immunoassay, Amphetamine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3100
- Specialty
- Clinical Toxicology
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More from Hangzhou Clongene Biotech Co., Ltd.
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|---|---|---|
| K131069 | Quickscreen Amphetine 500 TestDKZ · Traditional | 05/14/2014SE |
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| 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 Pro Multi Drug Screening Test, Model 9395Z cleared by the FDA?
QuickScreen Pro Multi Drug Screening Test, Model 9395Z (K181945) received a 510(k) decision of Substantially Equivalent on October 18, 2018, 90 days after the submission was received.
What is the product code of K181945?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.