The following data is part of a premarket notification filed by Sysmex America, Inc. with the FDA for Sysmex Poch-100i.
| Device ID | K032677 |
| 510k Number | K032677 |
| Device Name: | SYSMEX POCH-100I |
| Classification | Counter, Cell, Automated (particle Counter) |
| Applicant | SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein, IL 60060 |
| Contact | Chris Stukel |
| Correspondent | Chris Stukel SYSMEX AMERICA, INC. ONE NELSON C. WHITE PARKWAY Mundelein, IL 60060 |
| Product Code | GKL |
| CFR Regulation Number | 864.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-29 |
| Decision Date | 2004-02-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987562402021 | K032677 | 000 |