FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMICUS Separator System
K Number: K200530
·
Decision Sep 11, 2020
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
9
Applicant Total
12
Review Days
193
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Basic Information
- Device Name
- AMICUS Separator System
- K Number
- K200530
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.9245
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fresenius Kabi AG
- Date Received
- March 2, 2020
- Decision Date
- September 11, 2020
- Product Code
- GKT
- Advisory Committee
- Hematology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| GKT | Separator, Automated, Blood Cell, Diagnostic | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GKT), ordered by most recent decision date.
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