Title 21

SECTION 864.9320

864.9320 Copper sulfate solution for specific gravity determinations.

§ 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]

---