AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx
FDA 510(k) K233019 · Hangzhou AllTest Biotech Co., Ltd.
510(k) numberK233019
Submission
- Device name
- AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx
- Applicant
- Hangzhou AllTest Biotech Co., Ltd.
Hangzhou, CN - Received
- September 22, 2023
- Decision date
- December 13, 2023
- 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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| K240670 | DRI Ecstasy Plus AssayDKZ · Special | Microgenics Corporation | 10/30/2024SE |
| 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 |
| K191099 | Atlas Multi-Drugs Screening Test Cup, Atlas Multi-Drugs Screening Test PanelDKZ · Traditional | Atlas Medical | 10/03/2019SE |
| 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 |
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| 510(k) | Device | Decision |
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| K260342 | AllTest Strep A Rapid TestGTY · Traditional | 04/30/2026SE |
| K252607 | AllTest Urinary Tract Infection TestJMT · Traditional | 10/30/2025SE |
| K251053 | Shinetell PlusTM Digital Early Pregnancy TestLCX · Traditional | 07/15/2025SE |
| K250727 | AllTest Multi-Drug Rapid Urine Test Cup; AllTest Multi-Drug Urine Test CupNFT · Traditional | 04/04/2025SE |
| K242576 | AllTest Viral Transport MediumJSM · Traditional | 04/04/2025SE |
| K244043 | AllTest Multi-Drug Rapid Test Cup ; AllTest Multi-Drug Test CupNFT · Traditional | 02/27/2025SE |
| K242540 | AllTest Multi-Drug Urine Test Panel; AllTest Multi-Drug Rapid Urine Test PanelNFT · Traditional | 09/27/2024SE |
| K241978 | Shinetell Digital Pregnancy TestLCX · Traditional | 08/13/2024SE |
| K241428 | AllTest Multi-Drug Urine Test Cup ; AllTest Multi-Drug Rapid Urine Test CupNFT · Traditional | 06/17/2024SE |
| K233417 | AllTest Fentanyl Urine Test CassetteNGL · Traditional | 10/26/2023SE |
Questions and answers
When was AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx cleared by the FDA?
AllTest Multi-Drug Rapid Test Cup; AllTest Multi-Drug Rapid Test Panel; AllTest Multi-Drug Rapid Test Cup Rx; AllTest Multi-Drug Rapid Test Panel Rx (K233019) received a 510(k) decision of Substantially Equivalent on December 13, 2023, 82 days after the submission was received.
What is the product code of K233019?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.