{"data":{"id":"us/21-cfr-864.9320","jurisdiction":"us","citation":"21 CFR 864.9320","heading":"Copper sulfate solution for specific gravity determinations.","body":"(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).\n(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.","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 864—HEMATOLOGY AND PATHOLOGY DEVICES","Subpart J—Products Used In Establishments That Manufacture Blood and Blood Products"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"8d73e41a5e7bd77d32a5deb31e9b8713067b93e3bb612454122a8af81c46431b","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.9300","next":"us/21-cfr-864.9400"},"notice":"GroundRules: Original legal text. Not legal advice."}