Peace of Mind Home Drug Test
FDA 510(k) K013778 · Advantage Diagnostics Corp.
510(k) numberK013778
Submission
- Device name
- Peace of Mind Home Drug Test
- Applicant
- Advantage Diagnostics Corp.
Redwood City, CA, US - Received
- November 13, 2001
- Decision date
- February 7, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MVO – Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
- Device class
- Unclassified
Other 510(k)s with product code MVO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K040327 | Accu-Stat Home Drug Tests for Marijuana (THC) and for Marijuana & Cocaine (THC, Coc)MVO · Traditional | Accu-Stat Diagnostics, Inc. | 04/19/2004SE |
| K030447 | At Home Drug Cup, Model 9150XMVO · Special | Phamatech | 04/14/2003SE |
| K014192 | Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met, Status DS…MVO · Traditional | Princeton BioMeditech Corp. | 05/23/2002SE |
| K013412 | At Home Drug Test, Model 9069MVO · Special | Phamatech, Inc. | 12/06/2001SE |
| K013410 | At Home Drug Test, Model 9064MVO · Special | Phamatech, Inc. | 12/06/2001SE |
| K013409 | At Home Drug Test, Model 9074MVO · Special | Phamatech, Inc. | 12/06/2001SE |
| K010655 | At Home Drug Testt, Model 9150 TMVO · Special | Phamatech | 04/05/2001SE |
| K010654 | At Home Drug Test, Model 9078 TMVO · Special | Phamatech | 04/05/2001SE |
| K010653 | At Home Drug Test, Model 9068 TMVO · Special | Phamatech | 04/05/2001SE |
| K010646 | At Home Drug Test, Model 9083 TMVO · Special | Phamatech | 03/30/2001SE |
More from Phamatech
| 510(k) | Device | Decision |
|---|---|---|
| K023712 | Advantage Multiple Drugs of Abuse TestDKZ · Traditional | 01/31/2003SE |
| K011962 | Advantage Marijuana (THC) and Cocaine Home Drug TestDIO · Traditional | 08/09/2001SE |
| K010921 | Advantage Marijuana (THC) Home Drug TestLDJ · Traditional | 06/25/2001SE |
| K003708 | Advantage Thc/Cocaine TestDIO · Traditional | 01/22/2001SE |
| K001567 | Advantage THC TestLDJ · Traditional | 06/19/2000SE |
| K994227 | Advantage HCG Test (Urine/Serum)JHI · Traditional | 02/03/2000SE |
| K991883 | Redi-Test OpiatesDJG · Traditional | 09/15/1999SE |
| K903416 | Cannula, SurgicalGEA · Traditional | 11/23/1990SE |
| K881369 | Advance Diagnostics Disposable EyecupLXQ · Traditional | 05/13/1988SE |
Questions and answers
When was Peace of Mind Home Drug Test cleared by the FDA?
Peace of Mind Home Drug Test (K013778) received a 510(k) decision of Substantially Equivalent on February 7, 2002, 86 days after the submission was received.
What is the product code of K013778?
The FDA product code is MVO – Kit, Test, Multiple, Drugs Of Abuse, Over The Counter, a Unclassified device.