The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Sysmex Immature Reticulocyte Fraction (irf) Parameter.
| Device ID | K971736 |
| 510k Number | K971736 |
| Device Name: | SYSMEX IMMATURE RETICULOCYTE FRACTION (IRF) PARAMETER |
| Classification | Counter, Differential Cell |
| Applicant | SYSMEX CORP. GILMER RD. 6699 RFD Long Grove, IL 60047 -9596 |
| Contact | Catherine M Trester |
| Correspondent | Catherine M Trester 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 | 1997-05-12 |
| Decision Date | 1997-08-26 |
| Summary: | summary |