Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
FDA 510(k) K191099 · Atlas Medical
510(k) numberK191099
Submission
- Device name
- Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel
- Applicant
- Atlas Medical
Amman, JO - Received
- April 25, 2019
- Decision date
- October 3, 2019
- 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
Other 510(k)s with product code DKZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240670 | DRI Ecstasy Plus AssayDKZ · Special | Microgenics Corporation | 10/30/2024SE |
| K233019 | AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest…DKZ · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 12/13/2023SE |
| K231137 | Xenta Drug Screen Cup, Xenta Drug Screen DipcardDKZ · Traditional | Xenta Biomedical Science Co., Ltd. | 05/19/2023SE |
| K200363 | Quidel Triage® TOX Drug Screen, 94600DKZ · Special | Quidel Cardiovascular, Inc. | 03/11/2020SE |
| K182719 | Quidel Triage TOX Drug Screen, 94600; Quidel Triage® MeterProDKZ · Traditional | Quidel Cardiovascular, Inc. | 06/19/2019SE |
| K182738 | Single and Multi-Drug Rapid Test Panel With Adulteration (Urine), Single and Multi-Drug…DKZ · Traditional | Hangzhou AllTest Biotech Co., Ltd. | 03/27/2019SE |
| K180879 | BIO-VENTURE Rapid Multi-Drug Test Easy Cup for OTC Use, BIO-VENTURE Rapid Multi-Drug…DKZ · Traditional | Shanghai Venture Bio-Tech Co., Ltd. | 12/14/2018SE |
| K181945 | QuickScreen Pro Multi Drug Screening Test, Model 9395ZDKZ · Traditional | Phamatech, Inc. | 10/18/2018SE |
| K173303 | INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use), INSTANT-VIEW…DKZ · Traditional | Alfa Scientific Designs, Inc. | 02/23/2018SE |
| K161251 | CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam TestsDKZ · Traditional | Hangzhou Clongene Biotech Co., Ltd. | 08/30/2016SE |
More from Hangzhou Clongene Biotech Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K102760 | Atlas Home Pregnancy Test (Midstream Format) Model 70172001LCX · Traditional | 08/03/2011SE |
Questions and answers
When was Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel cleared by the FDA?
Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test Panel (K191099) received a 510(k) decision of Substantially Equivalent on October 3, 2019, 161 days after the submission was received.
What is the product code of K191099?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.