510(k) K991641
- Device
- AT HOME COCAINE & THC SCREENING TEST, MODEL 9170
- Applicant
- PHAMATECH
- 510(k) number
- K991641
- Product code
- MVO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-06-01
- Date received
- 1999-05-12
- Regulation
- 510(k) Premarket Notification
- Classification name
- Kit, Test, Multiple, Drugs Of Abuse, Over The Counter
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Toxicology
- Device class
- U
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- CARL A MONGIOVI
- Address
- 9265 Activity Rd., #112-113 San Diego CA US 92126 92126
FDA Registration Numbers#
- 3005360469
- 1832216
- 2031229
- 2029372
- 2246703
Source Documents#
Other 510(k) Records For Product Code MVO #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K040327 | ACCU-STAT HOME DRUG TESTS FOR MARIJUANA (THC) AND FOR MARIJUANA & COCAINE (THC, COC) | Accu-Stat Diagnostics, Inc. | 2004-04-19 |
| K030447 | AT HOME DRUG CUP, MODEL 9150X | Phamatech | 2003-04-14 |
| K014192 | LIFESIGN MET, STATUS STIK MET, ACCUSIGN STIK MET, ACCUSTIK MET, ACCUSIGN MET, STATUS DS MET | Princeton BioMeditech Corp. | 2002-05-23 |
| K013778 | PEACE OF MIND HOME DRUG TEST | Advantage Diagnostics Corp. | 2002-02-07 |
| K013409 | AT HOME DRUG TEST, MODEL 9074 | Phamatech, Inc. | 2001-12-06 |
| K013410 | AT HOME DRUG TEST, MODEL 9064 | Phamatech, Inc. | 2001-12-06 |
| K013412 | AT HOME DRUG TEST, MODEL 9069 | Phamatech, Inc. | 2001-12-06 |
| K010653 | AT HOME DRUG TEST, MODEL 9068 T | Phamatech | 2001-04-05 |
| K010654 | AT HOME DRUG TEST, MODEL 9078 T | Phamatech | 2001-04-05 |
| K010655 | AT HOME DRUG TESTT, MODEL 9150 T | Phamatech | 2001-04-05 |
| K010646 | AT HOME DRUG TEST, MODEL 9083 T | Phamatech | 2001-03-30 |
| K003858 | MODIFICATION TO AT HOME DRUG TEST, MODELS 9150, 9068, AND 9175 | Phamatech | 2001-02-12 |
| K991465 | DRUG STOP | Texas Immunology, Inc. | 1999-12-10 |
| K992685 | QUICKSCREEN WORKPLACE DRUG SCREENING TEST, MODEL 9147 25C | Phamatech | 1999-10-06 |
| K992217 | AT HOME DRUG TEST, MODEL 9175 | Phamatech | 1999-07-13 |
Legacy Summary#
summary
FDA Review#
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