ACCU NEWS Drug Screening Test Card/Urine Cup
FDA 510(k) K152590 · Coretests, Inc.
510(k) numberK152590
Submission
- Device name
- ACCU NEWS Drug Screening Test Card/Urine Cup
- Applicant
- Coretests, Inc.
Carlsbad, CA, US - Received
- September 10, 2015
- Decision date
- April 15, 2016
- 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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| 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 |
More from Alfa Scientific Designs, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K150063 | One Step hCG Pregnancy TestLCX · Traditional | 10/02/2015SE |
Questions and answers
When was ACCU NEWS Drug Screening Test Card/Urine Cup cleared by the FDA?
ACCU NEWS Drug Screening Test Card/Urine Cup (K152590) received a 510(k) decision of Substantially Equivalent on April 15, 2016, 218 days after the submission was received.
What is the product code of K152590?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.