Device Classification Name |
counter, differential cell
|
510(k) Number |
K180020 |
Device Name |
HemoScreen Hematology Analyzer |
Applicant |
PixCell Medical Technologies, Ltd. |
6 Hayezira St. |
yoknaem ilit,
IL
2069202
|
|
Applicant Contact |
yaaya ben-yosef |
Correspondent |
Erika B. Ammirati, RAC, MT (ASCP) |
575 Shirlynn Court |
los altos,
CA
94022
|
|
Correspondent Contact |
erika b. ammirati |
Regulation Number | 864.5220
|
Classification Product Code |
|
Date Received | 01/02/2018 |
Decision Date | 10/29/2018 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Hematology
|
510k Review Panel |
Hematology
|
summary |
summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|