FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
QUICKSCREEN, MODELS 9177X AND 9178X
K Number: K041578
·
Decision Sep 10, 2004
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
87
Applicant Total
47
Review Days
88
Basic Information
- Device Name
- QUICKSCREEN, MODELS 9177X AND 9178X
- K Number
- K041578
- Device Class
- FDA unclassified
- Clearance Type
- Special
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PHAMATECH
- Date Received
- June 14, 2004
- Decision Date
- September 10, 2004
- Product Code
- LCM
- Advisory Committee
- Unknown
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| LCM | Enzyme Immunoassay, Phencyclidine | FDA unclassified | Unknown |
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Other Clearances by PHAMATECH
| K Number | Device Name | ||
|---|---|---|---|
| K030447 | AT HOME DRUG CUP, MODEL 9150X | Apr 14, 2003 | Substantially Equivalent |
| K010836 | AT WORK DRUG TEST, MODEL 9147T AWT | Apr 11, 2001 | Substantially Equivalent |
| K010833 | AT WORK DRUG TEST, MODEL 9177T AWT | Apr 11, 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 |
| K010654 | AT HOME DRUG TEST, MODEL 9078 T | Apr 5, 2001 | Substantially Equivalent |
| K010651 | AT HOME DRUG TEST, MODEL 9133 T | Mar 30, 2001 | Substantially Equivalent |
| K010646 | AT HOME DRUG TEST, MODEL 9083 T | Mar 30, 2001 | Substantially Equivalent |
| K010645 | AT HOME DRUG TEST, MODEL 9063 T | Mar 30, 2001 | Substantially Equivalent |
| K010650 | AT HOME DRUG TEST, MODEL 9073 T | Mar 30, 2001 | Substantially Equivalent |