FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PEFAKIT APC-R FACTOR V LEIDEN CONTROLS
K Number: K042760
·
Decision Dec 22, 2004
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
98
Applicant Total
2
Review Days
78
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Basic Information
- Device Name
- PEFAKIT APC-R FACTOR V LEIDEN CONTROLS
- K Number
- K042760
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Pentapharm , Ltd.
- Date Received
- October 5, 2004
- Decision Date
- December 22, 2004
- Product Code
- GGN
- 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 |
|---|---|---|---|
| GGN | Plasma, Coagulation Control | FDA class 2 | Hematology |
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Other Clearances by Pentapharm , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K042762 | PEFAKIT APC-R FACTOR V LEIDEN | Dec 22, 2004 | Substantially Equivalent |