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e-CFR data is current as of September 16, 2020

Title 21Chapter ISubchapter HPart 864Subpart F → §864.5240


Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart F—Automated and Semi-Automated Hematology Devices


§864.5240   Automated blood cell diluting apparatus.

(a) Identification. An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing.

(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 60596, Sept. 12, 1980, as amended at 65 FR 2310, Jan. 14, 2000]

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