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 |