Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
A Multiple Drugs of Abuse Over-the-Counter Test Kit is an in vitro diagnostic device intended for consumer (non-prescription) use to screen for the presence of multiple illicit or controlled substances in urine samples. This device has an unclassified status (class "U") in the FDA database. The product code is MVO with no regulation number assigned, and the device is not an implant and is not life-sustaining.
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Basic Information
- Product Code
- MVO
- Device Class
- FDA unclassified
- Medical Specialty
- Unknown
- Review Panel
- TX
- Submission Type
- 1
Device Characteristics
Unclassified Reason
1
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 18 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K040327 | ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC) | Apr 19, 2004 | Substantially Equivalent | Accu-Stat Diagnostics, Inc. |
| K030447 | AT HOME DRUG CUP, MODEL 9150X | Apr 14, 2003 | Substantially Equivalent | Phamatech |
| K014192 | LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET | May 23, 2002 | Substantially Equivalent | Princeton BioMeditech Corp. |
| K013778 | PEACE OF MIND HOME DRUG TEST | Feb 07, 2002 | Substantially Equivalent | Advantage Diagnostics Corp. |
| K013412 | AT HOME DRUG TEST, MODEL 9069 | Dec 06, 2001 | Substantially Equivalent | Phamatech, Inc. |
| K013410 | AT HOME DRUG TEST, MODEL 9064 | Dec 06, 2001 | Substantially Equivalent | Phamatech, Inc. |
| K013409 | AT HOME DRUG TEST, MODEL 9074 | Dec 06, 2001 | Substantially Equivalent | Phamatech, Inc. |
| K010655 | AT HOME DRUG TESTT, MODEL 9150 T | Apr 05, 2001 | Substantially Equivalent | Phamatech |
| K010654 | AT HOME DRUG TEST, MODEL 9078 T | Apr 05, 2001 | Substantially Equivalent | Phamatech |
| K010653 | AT HOME DRUG TEST, MODEL 9068 T | Apr 05, 2001 | Substantially Equivalent | Phamatech |
| K010646 | AT HOME DRUG TEST, MODEL 9083 T | Mar 30, 2001 | Substantially Equivalent | Phamatech |
| K003858 | MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 | Feb 12, 2001 | Substantially Equivalent | Phamatech |
| K991465 | DRUG STOP | Dec 10, 1999 | Substantially Equivalent | Texas Immunology, Inc. |
| K992685 | QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C | Oct 06, 1999 | Substantially Equivalent | Phamatech |
| K992217 | AT HOME DRUG TEST, MODEL 9175 | Jul 13, 1999 | Substantially Equivalent | Phamatech |
| K991824 | AT HOME DRUG TEST, MODEL 9171 | Jun 11, 1999 | Substantially Equivalent | Phamatech |
| K991641 | AT HOME COCAINE & THC SCREENING TEST, MODEL 9170 | Jun 01, 1999 | Substantially Equivalent | Phamatech |
| K982621 | QUICKSCREEN AT HOME DRUG TEST, MODEL 9149/9150 | Oct 16, 1998 | Substantially Equivalent | Phamatech |
FEI Numbers
This FDA classification entry is associated with 5 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 5 registration numbers. Click on an entry to view related FDA registrations.