21 C.F.R. § 864.5400 Coagulation instrument.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 864—HEMATOLOGY AND PATHOLOGY DEVICES
Subpart F—Automated and Semi-Automated Hematology Devices
§ 864.5400 Coagulation instrument.
