Section 864.9320 - Copper sulfate solution for specific gravity determinations(a)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).(b)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 .45 FR 60647, Sept. 12, 1980, as amended at 65 FR 2310 , Jan. 14, 2000