The following data is part of a premarket notification filed by Fresenius Kabi Usa Llc with the FDA for Amicus Separator System, Amicus Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike And Luer Adapter.
| Device ID | K180615 |
| 510k Number | K180615 |
| Device Name: | AMICUS Separator System, AMICUS Exchange Kit - Therapeutics, Waste Transfer Set, Blood Component Filter Set With Vented Spike And Luer Adapter |
| Classification | Separator, Automated, Blood Cell And Plasma, Therapeutic |
| Applicant | Fresenius Kabi USA LLC Three Corporate Drive Lake Zurich, IL 60047 |
| Contact | Kim Forch |
| Correspondent | Kim Forch Fresenius Kabi USA LLC Three Corporate Drive Lake Zurich, IL 60047 |
| Product Code | LKN |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-08 |
| Decision Date | 2018-12-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04086000101950 | K180615 | 000 |
| 04052682031724 | K180615 | 000 |