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e-CFR data is current as of November 30, 2020

Title 21Chapter ISubchapter HPart 864Subpart F → §864.5350


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


§864.5350   Microsedimentation centrifuge.

(a) Identification. A microsedimentation centrifuge is a device used to sediment red cells for the microsedimentation rate test.

(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 60598, Sept. 12, 1980, as amended at 59 FR 63007, Dec. 7, 1994; 66 FR 38789, July 25, 2001]

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