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Electronic Code of Federal Regulations

e-CFR data is current as of May 21, 2020

Title 21Chapter ISubchapter HPart 864Subpart F → §864.5400


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


§864.5400   Coagulation instrument.

(a) Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.

(b) Classification. Class II (special controls). A fibrometer or coagulation timer intended for use with a coagulation instrument 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 84 FR 71799, Dec. 30, 2019]

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