 |
Code of Federal Regulations (Last Updated: July 5, 2024) |
 |
Title 21 - Food and Drugs |
|
Chapter I - Food and Drug Administration, Department of Health and Human Services |
|
SubChapter H - Medical Devices |
|
Part 864 - Hematology and Pathology Devices |
|
Subpart G - Manual Hematology Devices |
§ 864.6675 - Platelet aggregometer.
Latest version.
-
§ 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).
[45 FR 60608, Sept. 12, 1980]