FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FACTOR V DEFICIENT PLASMA
K Number: K900406
·
Decision Mar 6, 1990
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
78
Applicant Total
231
Review Days
36
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Basic Information
- Device Name
- FACTOR V DEFICIENT PLASMA
- K Number
- K900406
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Sigma Chemical Co.
- Date Received
- January 29, 1990
- Decision Date
- March 6, 1990
- Product Code
- GJT
- 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 |
|---|---|---|---|
| GJT | Plasma, Coagulation Factor Deficient | FDA class 2 | Hematology |
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