AMICUS Separator System
FDA 510(k) clearance K192150 · decided 2019-11-13
Clearance details
- K-number
- K192150
- Device name
- AMICUS Separator System
- Applicant
- Fresenius Kabi AG
- Decision
- Substantially Equivalent
- Date received
- 2019-08-09
- Decision date
- 2019-11-13
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- LKN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Bad Homburg, DE
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.