The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Sysmex Sf-3000.
| Device ID | K950508 |
| 510k Number | K950508 |
| Device Name: | SYSMEX SF-3000 |
| Classification | Tubing, Fluid Delivery |
| Applicant | SYSMEX CORP. 6699 RFD Long Grove, IL 60047 -9596 |
| Contact | Nina Gamperling |
| Correspondent | Nina Gamperling SYSMEX CORP. 6699 RFD Long Grove, IL 60047 -9596 |
| Product Code | FPK |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-06 |
| Decision Date | 1995-11-03 |