← Product Code [KRZ](/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ) · K902892

# CELL-DYN CALIBRATOR (K902892)

_Unipath , Ltd. · KRZ · Sep 10, 1990 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K902892

## Device Facts

- **Applicant:** Unipath , Ltd.
- **Product Code:** [KRZ](/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ.md)
- **Decision Date:** Sep 10, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.8165
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose 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/KRZ/K902892](https://fda.innolitics.com/submissions/HE/subpart-i%E2%80%94hematology-reagents/KRZ/K902892)

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