CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 864—HEMATOLOGY AND PATHOLOGY DEVICES > SUBPART F—Automated and Semi-Automated Hematology Devices (§864.5200 to §864.5950) > 864.5400—Coagulation instrument.

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 (performance standards).

Code of Federal Regulations

[45 FR 60598, Sept. 12, 1980]