§864.9320. Copper sulfate solution for specific gravity determinations.
21 C.F.R. § 864.9320
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.
Notes, amendments, and revision history
Amendments
[45 FR 60647, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Amendments
[45 FR 60647, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]