← Product Code [JPJ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPJ) · K904675

# QBC SYSTEM MCHC (K904675)

_Bd Becton Dickinson Vacutainer Systems Preanalytic · JPJ · Nov 2, 1990 · Hematology · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPJ/K904675

## Device Facts

- **Applicant:** Bd Becton Dickinson Vacutainer Systems Preanalytic
- **Product Code:** [JPJ](/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPJ.md)
- **Decision Date:** Nov 2, 1990
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 864.5300
- **Device Class:** Class 2
- **Review Panel:** Hematology

## Regulatory Identification

A red cell indices device, usually part of a larger system, calculates or directly measures the erythrocyte mean corpuscular volume (MCV), the mean corpuscular hemoglobin (MCH), and the mean corpuscular hemoglobin concentration (MCHC). The red cell indices are used for the differential diagnosis of anemias.

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**Source:** [https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPJ/K904675](https://fda.innolitics.com/submissions/HE/subpart-f%E2%80%94automated-and-semi-automated-hematology-devices/JPJ/K904675)

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