FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUICKSTICK PRO HCG TEST
K Number: K974615
·
Decision Jan 26, 1998
Classifications
1
FEI Numbers
102
Registration Numbers
102
Same Product Code
374
Applicant Total
47
Review Days
46
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Basic Information
- Device Name
- QUICKSTICK PRO HCG TEST
- K Number
- K974615
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1155
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Phamatech
- Date Received
- December 11, 1997
- Decision Date
- January 26, 1998
- Product Code
- JHI
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | FDA class 2 | Clinical Chemistry |
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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 |