HEMOGLOBIN SCREENING DEVICE
Device Facts
| Record ID | K882101 |
|---|---|
| Device Name | HEMOGLOBIN SCREENING DEVICE |
| Applicant | Portable Medical Laboratories, Inc. |
| Product Code | KSL · Hematology |
| Decision Date | Jul 1, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 864.9320 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A copper sulfate solution for specific gravity determinations is a device used to determine whether the hemoglobin content of a potential donor's blood meets the required level (12.5 grams per 100 milliliters of blood for women and 13.5 grams per 100 milliliters of blood for men).
