21 CFR 864.6675 — Aggregometer, Platelet, Thrombokinetogram

Hematology (HE) · Part 864 Subpart G—Manual Hematology Devices · § 864.6675

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.

Classification Rationale

Class II (performance standards).

Product Codes

Product CodeDevice NameClassDevicesAttributes
GKWAggregometer, Platelet, Thrombokinetogram203rd Party
JBXAggregrometer, Platelet2123rd Party
JBYAggregometer, Platelet, Photo-Optical Scanning223rd Party
Innolitics

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