21 CFR 864.5240 — Apparatus, Automated Blood Cell Diluting

Hematology (HE) · Part 864 Subpart F—Automated and Semi-Automated Hematology Devices · § 864.5240

Identification

An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing.

Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 864.9.

Product Codes

Product CodeDevice NameClassDevicesAttributes
GKHApparatus, Automated Blood Cell Diluting114
Innolitics

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