The following data is part of a premarket notification filed by Sysmex Corp. with the FDA for Sysmex Se/ram-1.
Device ID | K964375 |
510k Number | K964375 |
Device Name: | SYSMEX SE/RAM-1 |
Classification | Counter, Cell, Automated (particle Counter) |
Applicant | SYSMEX CORP. GILMER RD. 6699 RFD Long Grove, IL 60047 -9596 |
Contact | Catherine M Trester, Mt(ascp) |
Correspondent | Catherine M Trester, Mt(ascp) SYSMEX CORP. GILMER RD. 6699 RFD Long Grove, IL 60047 -9596 |
Product Code | GKL |
CFR Regulation Number | 864.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-11-01 |
Decision Date | 1997-03-13 |
Summary: | summary |