← Product Code [KRY](/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRY) · K862122

# S-CAL HEMATOLOGY CALIBRATOR (K862122)

_Coulter Electronics, Inc. · KRY · May 20, 1987 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRY/K862122

## Device Facts

- **Applicant:** Coulter Electronics, Inc.
- **Product Code:** [KRY](/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRY.md)
- **Decision Date:** May 20, 1987
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.8175
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory 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.

## Special Controls

*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.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRY/K862122](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRY/K862122)

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