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Code of Federal Regulations (Last Updated: July 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 864 - Hematology and Pathology Devices |
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Subpart J - Products Used In Establishments That Manufacture Blood and Blood Products |
§ 864.9320 - Copper sulfate solution for specific gravity determinations.
Latest version.
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§ 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]