First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Met), Ecstasy
FDA 510(k) K052115 · First Check Diagnostics, LLC
510(k) numberK052115
Submission
- Device name
- First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Met), Ecstasy
- Applicant
- First Check Diagnostics, LLC
Lake Forest, CA, US - Received
- August 4, 2005
- Decision date
- December 29, 2005
- 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 |
| 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 |
Questions and answers
When was First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Met), Ecstasy cleared by the FDA?
First Check Multi Drug Cup 12 for Marijuana (THC), Cocaine (Coc), Amphetamine (Amp), Methamphetamine (Met), Ecstasy (K052115) received a 510(k) decision of Substantially Equivalent on December 29, 2005, 147 days after the submission was received.
What is the product code of K052115?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.