§ 864.9320. Copper sulfate solution for specific gravity determinations.
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/us/cfr/t21/s§ 864.9320·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]