← Product Code [KSL](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSL) · K803095

# COPPER SULFATE SOLUTION SP. GR.1.055 (K803095)

_Accra Laboratories, Inc. · KSL · Mar 6, 1981 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSL/K803095

## Device Facts

- **Applicant:** Accra Laboratories, Inc.
- **Product Code:** [KSL](/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSL.md)
- **Decision Date:** Mar 6, 1981
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.9320
- **Device Class:** Class 1
- **Review Panel:** Hematology

## Regulatory 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).

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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/K803095](https://fda.innolitics.com/submissions/HE/subpart-j%E2%80%94products-used-in-establishments-that-manufacture-blood-and-blood-products/KSL/K803095)

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