FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AT HOME DRUG TEST, MODEL 9068
K Number: K994233
·
Decision Dec 30, 1999
Classifications
1
FEI Numbers
64
Registration Numbers
64
Same Product Code
48
Applicant Total
47
Review Days
14
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Basic Information
- Device Name
- AT HOME DRUG TEST, MODEL 9068
- K Number
- K994233
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 862.3610
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phamatech
- Date Received
- December 16, 1999
- Decision Date
- December 30, 1999
- Product Code
- LAF
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LAF | Gas Chromatography, Methamphetamine | FDA class 2 | Clinical Toxicology |
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Other Clearances by Phamatech
| K Number | Device Name | ||
|---|---|---|---|
| K041578 | QUICKSCREEN, MODELS 9177X AND 9178X | Sep 10, 2004 | Substantially Equivalent |
| K030447 | AT HOME DRUG CUP, MODEL 9150X | Apr 14, 2003 | Substantially Equivalent |
| K010833 | AT WORK DRUG TEST, MODEL 9177T AWT | Apr 11, 2001 | Substantially Equivalent |
| K010836 | AT WORK DRUG TEST, MODEL 9147T AWT | Apr 11, 2001 | Substantially Equivalent |
| K010654 | AT HOME DRUG TEST, MODEL 9078 T | Apr 5, 2001 | Substantially Equivalent |
| K010653 | AT HOME DRUG TEST, MODEL 9068 T | Apr 5, 2001 | Substantially Equivalent |
| K010655 | AT HOME DRUG TESTT, MODEL 9150 T | Apr 5, 2001 | Substantially Equivalent |
| K010645 | AT HOME DRUG TEST, MODEL 9063 T | Mar 30, 2001 | Substantially Equivalent |
| K010646 | AT HOME DRUG TEST, MODEL 9083 T | Mar 30, 2001 | Substantially Equivalent |
| K010651 | AT HOME DRUG TEST, MODEL 9133 T | Mar 30, 2001 | Substantially Equivalent |