The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Fluid, Rhemox W Lysing.
Device ID | K790029 |
510k Number | K790029 |
Device Name: | FLUID, RHEMOX W LYSING |
Classification | Products, Red-cell Lysing Products |
Applicant | SYSMEX CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | GGK |
CFR Regulation Number | 864.8540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-01-03 |
Decision Date | 1979-02-26 |