21 CFR § 864.8175 - Calibrator for platelet counting.

---
identifier: "/us/cfr/t21/s864.8175"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 864.8175 - Calibrator for platelet counting."
title_number: 21
title_name: "Food and Drugs"
section_number: "864.8175"
section_name: "Calibrator for platelet counting."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "864"
part_name: "HEMATOLOGY AND PATHOLOGY DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
cfr_part: "864"
---


# 864.8175 Calibrator for platelet counting.

(a) *Identification.* A calibrator for platelet counting is a device that resembles platelets in plasma or whole blood and that is used to set a platelet counting instrument. It is a suspension of particles or cells whose size, shape concentration, and other characteristics have been precisely and accurately determined.

(b) *Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.

[45 FR 60633, Sept. 12, 1980, as amended at 84 FR 71800, Dec. 30, 2019]