21 CFR § 864.6675
Platelet aggregometer
June 25, 2020
(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).
[45 FR 60608, Sept. 12, 1980]