FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA
K Number: K924396
·
Decision May 21, 1993
Classifications
1
FEI Numbers
12
Registration Numbers
12
Same Product Code
78
Applicant Total
145
Review Days
263
Basic Information
- Device Name
- CLOTTING FACTOR-VIII-IX-XI-XII DEFICIENT PLASMA
- K Number
- K924396
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7290
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BEHRING DIAGNOSTICS, INC.
- Date Received
- August 31, 1992
- Decision Date
- May 21, 1993
- 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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