FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MULTI-CENTRIFUGE
K Number: K955795
·
Decision Mar 29, 1996
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
10
Applicant Total
1
Review Days
98
Basic Information
- Device Name
- MULTI-CENTRIFUGE
- K Number
- K955795
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.6400
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- NOVONX, INC.
- Date Received
- December 22, 1995
- Decision Date
- March 29, 1996
- Product Code
- GKG
- 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 |
|---|---|---|---|
| GKG | Centrifuge, Hematocrit | FDA class 2 | Hematology |
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