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. 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.
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