The following data is part of a premarket notification filed by Pixcell Medical Technologies, Ltd. with the FDA for Hemoscreen Hematology Analyzer.
| Device ID | K180020 |
| 510k Number | K180020 |
| Device Name: | HemoScreen Hematology Analyzer |
| Classification | Counter, Differential Cell |
| Applicant | PixCell Medical Technologies, Ltd. 6 Hayezira St. Yoknaem Ilit, IL 2069202 |
| Contact | Yaaya Ben-yosef |
| Correspondent | Erika B. Ammirati Erika B. Ammirati, RAC, MT (ASCP) 575 Shirlynn Court Los Altos, CA 94022 |
| Product Code | GKZ |
| CFR Regulation Number | 864.5220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-01-02 |
| Decision Date | 2018-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07290016991048 | K180020 | 000 |
| 07290016991024 | K180020 | 000 |
| 07290016991000 | K180020 | 000 |
| 17290016991076 | K180020 | 000 |