Browse hierarchy: [Hematology (HE)](/submissions/HE) → [Subpart J — Products Used In Establishments That Manufacture Blood and Blood Products](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products) → [21 CFR 864.9320](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9320) → KSL — Solution, Copper Sulfate For Specific Gravity Determinations

# KSL · Solution, Copper Sulfate For Specific Gravity Determinations

_Hematology · 21 CFR 864.9320 · Class 1_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSL

## Overview

- **Product Code:** KSL
- **Device Name:** Solution, Copper Sulfate For Specific Gravity Determinations
- **Regulation:** [21 CFR 864.9320](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/864.9320)
- **Device Class:** 1
- **Review Panel:** [Hematology](/submissions/HE)

## 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](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSL/K882101.md) | HEMOGLOBIN SCREENING DEVICE | Portable Medical Laboratories, Inc. | Jul 1, 1988 | SESE |
| [K803095](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSL/K803095.md) | 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

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSL](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSL)

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