At Home Drug Test, Model 9069
FDA 510(k) K013412 · Phamatech, Inc.
510(k) numberK013412
Submission
- Device name
- At Home Drug Test, Model 9069
- Applicant
- Phamatech, Inc.
San Diego, CA, US - Received
- October 15, 2001
- Decision date
- December 6, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| K013778 | Peace of Mind Home Drug TestMVO · Traditional | Advantage Diagnostics Corp. | 02/07/2002SE |
| 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 |
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| K070098 | Quickscreen Barbiturate 300 Screening Test, Models 9019, 9018; Multi Drug Screening…DIS · Traditional | 12/07/2007SE |
| K070009 | At Home Drug Test Models, 9308T and 9308XDIS · Traditional | 12/07/2007SE |
| K043599 | Moments Menopause Check, Model 9113CGJ · Special | 02/25/2005SE |
| K043051 | Quickscreen Oxycodone Test, Models 9120, 9120T, 9120X and 9121DJG · Traditional | 02/07/2005SE |
| K043167 | Phamatech Quickscreen Benzodiazepines Test, Models 9025, 9026, 9027T, 9153T and 9195XJXM · Special | 12/29/2004SE |
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Questions and answers
When was At Home Drug Test, Model 9069 cleared by the FDA?
At Home Drug Test, Model 9069 (K013412) received a 510(k) decision of Substantially Equivalent on December 6, 2001, 52 days after the submission was received.
What is the product code of K013412?
The FDA product code is MVO – Kit, Test, Multiple, Drugs Of Abuse, Over The Counter, a Unclassified device.