PART 864 -- HEMATOLOGY AND PATHOLOGY DEVICES
Subpart F--Automated and Semi-Automated Hematology Devices
(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 (performance standards).
[45 FR 60598, Sept. 12, 1980]
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