KSL · Solution, Copper Sulfate For Specific Gravity Determinations
Hematology · 21 CFR 864.9320 · Class 1
Overview
| Product Code | KSL |
|---|---|
| Device Name | Solution, Copper Sulfate For Specific Gravity Determinations |
| Regulation | 21 CFR 864.9320 |
| Device Class | Class 1 |
| Review Panel | Hematology |
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).
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K882101 | HEMOGLOBIN SCREENING DEVICE | Portable Medical Laboratories, Inc. | Jul 1, 1988 | SESE |
| K803095 | COPPER SULFATE SOLUTION SP. GR.1.055 | Accra Laboratories, Inc. | Mar 6, 1981 | SESE |
Top Applicants
- Accra Laboratories, Inc. — 1 clearance
- Portable Medical Laboratories, Inc. — 1 clearance
