COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA
Device Facts
| Record ID | K874188 |
|---|---|
| Device Name | COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA |
| Applicant | Coulter Electronics, Inc. |
| Product Code | GKM · Hematology |
| Decision Date | Jan 19, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.6160 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A manual blood cell counting device is a device used to count red blood cells, white blood cells, or blood platelets.
