First Sign Drug of Abuse Screening Test
FDA 510(k) K032575 · W.H.P.M., Inc.
510(k) numberK032575
Submission
- Device name
- First Sign Drug of Abuse Screening Test
- Applicant
- W.H.P.M., Inc.
Beverly, MA, US - Received
- August 20, 2003
- Decision date
- May 19, 2004
- 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 |
|---|---|---|
| K200754 | Hemosure Accu-Reader A100OOX · Traditional | 06/02/2022SE |
| K210327 | First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign…QBF · Traditional | 08/12/2021SE |
| K171695 | First Sign Multi-Drug Dip Card Test, First Sign Multi-Drug Cup Test, First Sign Drug of…NFT · Traditional | 02/05/2018SE |
| K160793 | First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of…DJR · Traditional | 08/17/2016SE |
| K152551 | First Sign® Drug of Abuse Buprenorphine Cup Test, First Sign® Drug of Abuse…DJG · Traditional | 11/09/2015SE |
| K151441 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestDJR · Traditional | 06/29/2015SE |
| K150162 | First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup TestLAF · Traditional | 02/26/2015SE |
| K142353 | First Sign Drug of Abuse Dip Card Test/First Sign Drug of Abuse Cup TestDIO · Traditional | 10/07/2014SE |
| K052197 | First Sign Drug of Abuse Urine Screening TestDJR · Traditional | 06/09/2006SE |
| K051841 | WH Accu Test One-Step Urine/Serum Combo Pregnancy TestJHI · Traditional | 08/22/2005SE |
Questions and answers
When was First Sign Drug of Abuse Screening Test cleared by the FDA?
First Sign Drug of Abuse Screening Test (K032575) received a 510(k) decision of Substantially Equivalent on May 19, 2004, 273 days after the submission was received.
What is the product code of K032575?
The FDA product code is DKZ – Enzyme Immunoassay, Amphetamine, a Class II (moderate risk) device regulated under 21 CFR 862.3100.