← Product Code [KRX](/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRX) · K862858

# CBC-CAL (TM) PLUS/MULTIPLE (K862858)

_R&D Systems, Inc. · KRX · Aug 21, 1986 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRX/K862858

## Device Facts

- **Applicant:** R&D Systems, Inc.
- **Product Code:** [KRX](/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRX.md)
- **Decision Date:** Aug 21, 1986
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.8150
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. 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/KRX/K862858](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRX/K862858)

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