CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS
Device Facts
| Record ID | K894389 |
|---|---|
| Device Name | CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS |
| Applicant | Catachem, Inc. |
| Product Code | GGX · Hematology |
| Decision Date | Oct 12, 1989 |
| 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.
