Title 21: Food and Drugs
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/ PART 864 - HEMATOLOGY AND PATHOLOGY DEVICES
/ Subpart I - Hematology Reagents / § 864.8200 Blood cell diluent.
§ 864.8200 Blood cell diluent.
(a) Identification. A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.
(b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.