The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Sysmex(tm) F-820, 520.
| Device ID | K945837 |
| 510k Number | K945837 |
| Device Name: | SYSMEX(TM) F-820, 520 |
| Classification | Counter, Differential Cell |
| Applicant | SYSMEX CORP. GILMER RD. 6699 RFD Long Grove, IL 60047 -9596 |
| Contact | Stan Stoklosa |
| Correspondent | Stan Stoklosa SYSMEX CORP. GILMER RD. 6699 RFD Long Grove, IL 60047 -9596 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-29 |
| Decision Date | 1995-06-09 |