§ 864.9320Copper 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]
Title 21 published on 2014-04-01
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