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Electronic Code of Federal Regulations

e-CFR data is current as of June 2, 2020

Title 21Chapter ISubchapter HPart 864Subpart I → §864.8200


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart I—Hematology Reagents


§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.

[45 FR 60635, Sept. 12, 1980, as amended at 54 FR 25045, June 12, 1989; 66 FR 38790, July 25, 2001]

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