FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
K Number: K882325
·
Decision Aug 25, 1988
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
51
Applicant Total
82
Review Days
80
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Basic Information
- Device Name
- UNIFAST ACTIVATED PARTIAL THROMBOPLASTIN TIME TEST
- K Number
- K882325
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7925
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Sclavo, Inc.
- Date Received
- June 6, 1988
- Decision Date
- August 25, 1988
- Product Code
- GFO
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| GFO | Activated Partial Thromboplastin | FDA class 2 | Hematology |
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|---|---|---|---|
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