{"data":{"id":"us/21-cfr-864.2875","jurisdiction":"us","citation":"21 CFR 864.2875","heading":"Balanced salt solutions or formulations.","body":"(a) Identification. A balanced salt solution or formulation is a defined mixture of salts and glucose in a simple medium. This device is included as a necessary component of most cell culture systems. This media component controls for pH, osmotic pressure, energy source, and inorganic ions.\n(b) Classification. Class I (general controls). These devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 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 C—Cell And Tissue Culture 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":"ed11337d42a399f9c3fa6e9cf6447e01d1a6c8a1fd063c265520ce458afcfbb7","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-864.2800","next":"us/21-cfr-864.3010"},"notice":"GroundRules: Original legal text. Not legal advice."}