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 G—Manual Hematology Devices (§864.6100 to §864.6700) > 864.6675—Platelet aggregometer.

864.6675—Platelet aggregometer.

(a) Identification. A platelet aggregometer is a device, used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet rich plasma.
(b) Classification. Class II (performance standards).

Code of Federal Regulations

[45 FR 60608, Sept. 12, 1980]