The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Fluid, Rhemox-hb Lysing.
| Device ID | K790030 |
| 510k Number | K790030 |
| Device Name: | FLUID, RHEMOX-HB LYSING |
| Classification | System, Hemoglobin, Automated |
| Applicant | SYSMEX CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GKR |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-01-03 |
| Decision Date | 1979-02-08 |