Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met, Status DS Met
FDA 510(k) K014192 · Princeton BioMeditech Corp.
510(k) numberK014192
Submission
- Device name
- Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met, Status DS Met
- Applicant
- Princeton BioMeditech Corp.
Monmouth Junction, NJ, US - Received
- December 21, 2001
- Decision date
- May 23, 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
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|---|---|---|---|
| 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 |
| K013778 | Peace of Mind Home Drug TestMVO · Traditional | Advantage Diagnostics Corp. | 02/07/2002SE |
| 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 |
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Questions and answers
When was Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met, Status DS Met cleared by the FDA?
Lifesign Met, Status Stik Met, Accusign Stik Met, Accustik Met, Accusign Met, Status DS Met (K014192) received a 510(k) decision of Substantially Equivalent on May 23, 2002, 153 days after the submission was received.
What is the product code of K014192?
The FDA product code is MVO – Kit, Test, Multiple, Drugs Of Abuse, Over The Counter, a Unclassified device.